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The pagewriter tc30/50/70 cardiograph device could potentially fail to charge while plugged into the ac power outlet. This is due to a faulty mainboard. based on a supplier analysis, the faulty mainboard was caused by…

After initiating testing by a third-party lab, it was discovered that the tested lots did not meet the astm d6319 standard for medical gloves. Initial testing was received on March 4, 2022 and communicated to the original manufacturer. Confirmatory third…

Potential for blood leak to occur with the anti-reflux valve upon treatment completion. Recall start date: May 5, 2022.

Draeger has become aware of cases in which the diva sevoflurane modules (part number:MK01703) stopped agent delivery during application of high fresh gas flow and high agent percentage. Recall start date: Apr 6, 2022

Stryker has identified a potential nonconformance for five lots of Smart Toe II implants (three of which have been imported into Canada). Specifically, the nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in…

The service pack (full version and delta package) NX VA20A-SP06 (VA20A-04T4) contains improvements concerning performance and stability. - Image reconstruction failure solved - Petra sequence image text corrected - New LW for RCCS_2G to support new…

A review of complaints on Sureform PNs 480445, 480545, 480460 was done to determine rate of harm due to tissue pushout events. This action was completed as part of an internal capa. Sureform complaint data from October 1, 2019 through September 30, 2021…

Under certain sporadic circumstances the Sensis Vibe Hemo System with VD12A software the Co (cardiac output) measurement using the thermodilution method will temporarily no longer be possible. This happens without any obvious reason. When the issue…

This update is specifically targeted to improve the robustness of the sequoia caster-assembly. The front casters cannot fall of the Sequoia system, since the wheel locking/swivel control rod runs through the caster shaft. If the bolt comes out, the…

Siemens Healthcare is notifying customer of a potential failure in the clip store function on the Acuson Juniper ultrasound system. In Juniper 1.0 the clip store function does not work when the ultrasound system has a disk full error. The purpose of this…

GE healthcare (GEHC) MR systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Failure to have proper venting could present a safety issue if the cryogen gas is vented into the MR room during a magnet…

GE Healthcare (GEHC) MR systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Failure to have proper venting could present a safety issue if the cryogen gas is vented into the MR room during a magnet…

Affected slides failed to conform to performance characteristics and the Csan Pronto Test Strips were not filling properly when a sample was loaded due to the formation of bubbles. Recall start date: November 18, 2021. 

Reports from the field indicated that customers were experiencing problems with the Trivantage EMG tubes such as having difficulty passing the electrode check screen on the NIM mainframe immediately after intubating the patient, losing the connection…

Baxter is communicating important safety information for Spectrum V8 and Spectrum IQ Infusion Pumps related to potential reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of…