Medical Devices Recalls

Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on the MODULAR ANALYTICS P module. this issue can lead to erroneous low CRPHS results. CRPHS is used as a marker for the prediction of cardiovascular risk. An erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination.

GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.

Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Software error. Potential for incorrect results

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

System may lock up.

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10  15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.

GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.

Outer Packaging is not sterile

Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage 4X10 due to contamination of the products with common mold (Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum)..

under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the software function [AutoQC as follow-up] is configured to run all three levels of AutoQC only after a Fluid Pack change, but not after a Sensor Cartridge change. When both are changed simultaneously, starting with the Sensor Cartridge and followed by the Fluid Pack, the analyzer carries out only the follow-up actions associated with the Sensor Cartridge change after completing the change workflow. As a result, no follow-up AutoQC is performed and the three expected AutoQC measurements for the Fluid Pack change are not carried out. Without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: pH, PO2, PCO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, SO2, O2Hb, COHb, MetHb, HHb, and Bili.