Medical equipment, implants, and diagnostic devices
Integra LifeSciences
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Fujifilm Medical Systems U.S.A.
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.
Philips Medical Systems (Cleveland)
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Integra York PA
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
Windstone Medical Packaging
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Fujifilm Medical Systems U.S.A.
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Olympus Corporation of the Americas
New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Compromised sterility due to breach of barrier
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
Pentax Medical Company
Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
MicroAire Surgical Instruments
MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
Compromised sterility due to breach of barrier
Leica Microsystems
Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
Fujifilm Medical Systems U.S.A.
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
Philips Medical Systems (Cleveland)
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.