All Recalls

Potential safety issue where a patient may be harmed while preparing for or during a scan.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.