Diagnostic Equipment

In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) Pixel Spacing and, (0018,1164) Imager Pixel Spacing. Because the estimated magnification factor is not used, distance meas

GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.

High positive calcium bias on plasma sample versus results on serum

RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.

Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage

Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.

Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.

2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup

Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.

Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open

It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.

Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.

Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.

Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.

Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10

Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and

Kits incompatible with certain fluorescence microscope light sources

STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.