Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Abaxis
Class I - Dangerous
Incorrect reference ranges of analytes.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade.
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
Siemens Medical Solutions USA
Class I - Dangerous
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Device and tray that houses the device did not pass steam sterilization process validation testing
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Class I - Dangerous
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Class I - Dangerous
Incorrect expiration date
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Leica ARveo and M530 OH6 microscope systems.
Leica Microsystems
Class I - Dangerous
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
Class I - Dangerous
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Class I - Dangerous
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Resource Optimization & Innovation
Class I - Dangerous
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Class I - Dangerous
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.