Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Syphilis Assay Interference with HBsAg Assay
In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner.
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Class I - Dangerous
Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (M¿V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Class I - Dangerous
A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.
Class I - Dangerous
The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
Class I - Dangerous
Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (M¿V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient
The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Sunquest Information Systems
Class I - Dangerous
In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.
Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Medtronic Navigation
Class I - Dangerous
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
Class I - Dangerous
GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
GE OEC Medical Systems
Class I - Dangerous
X-ray units did not meet manufacturer's specification for linearity.
Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causing the battery to overheat.
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Sunquest Information Systems
Class I - Dangerous
Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.