Medical equipment, implants, and diagnostic devices
LAP of America Laser Applications
Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)
Leica Microsystems
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.
There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
Davol, Inc., Subs. C. R. Bard
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).
Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Davol, Inc., Subs. C. R. Bard
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Philips Medical Systems (Cleveland)
During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.
Toshiba American Medical Systems
Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
Davol, Inc., Subs. C. R. Bard
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.
Davol, Inc., Subs. C. R. Bard
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Davol, Inc., Subs. C. R. Bard
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.
It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.