Medical device recalls

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

Potential for incomplete scan due to unstable connection inside of floating sensor.

Devices are not suitable for organ transplant.

Devices are not suitable for organ transplant.

Devices are not suitable for organ transplant.

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).

Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

Butyrate tube cracks during actuation, rendering product unusable.

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)

Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Safety and efficacy of dialysis acid concentrate cannot be assured

Safety and efficacy of dialysis acid concentrate cannot be assured

Safety and efficacy of dialysis acid concentrate cannot be assured

Safety and efficacy of dialysis acid concentrate cannot be assured

Safety and efficacy of dialysis acid concentrate cannot be assured

Safety and efficacy of dialysis acid concentrate cannot be assured

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.