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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.

Sorin Group USA

Class I - Dangerous

Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.

Sep 29, 2016 Implants & Prosthetics Nationwide View Details →

MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red Stripe Pressure Tubing and Color Plug, Item No. 46104-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

Transpac¿ w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item No. 46101-82 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

TRANSPAC¿ IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH AND MACRODRIP (POLE MOUNT), Item No. 42606-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

Transpac¿ IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device and Needleless Valves, Item No. 46112-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →

SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles

Siemens Medical Solutions USA

Class I - Dangerous

Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.

Nov 2, 2016 Other Medical Devices Nationwide View Details →

TRANSPAC¿ IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING, 2 SQUEEZE FLUSHES, 2 DISPOSABLE TRANSDUCER, MACRODRIP (POLE MOUNT), Item No. 42500-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Sep 27, 2016 Diagnostic Equipment Nationwide View Details →