Other Medical Devices

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

The feeding spike sets may leak at the interface of the tube and spike connector.

Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

The feeding spike sets may leak at the interface of the tube and spike connector.

The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions [21 CFR 1020.40(c)(1)] due to an insufficient safety margin for the means of attachment of a piece of interior x-ray shielding. Double sided industrial tape was used for attachment - there have been only 2 instances of detachment and although the piece of shielding detached it remained mostly in place supported by wires that pass through that piece of shielding. The repair is accomplished by adding a bracket to fasten the piece of shielding securely to the inside of the x-ray system. Mfr reports that no systems were found to have exceeded the emission limit when checked prior to repair.

The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.