Medical Devices Recalls

Complaints of leakage of insufflation gas through the device.

The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth.

The products are labeled as sterile but were not sterilized.

The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

Complaints of leakage of insufflation gas through the device.

Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.

Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.

Complaints of leakage of insufflation gas through the device.

The products are labeled as sterile but were not sterilized.

Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.

Complaints of leakage of insufflation gas through the device.

Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.

There is a potential for incorrect results to be reported from processing of a sample tube.

The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.

Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teethe Coco the Monkey", Model Number 206-647, because the tail of the monkey may pose a choking hazard to young children.

Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

Potential for dose errors due to software program errors.

Complaints of leakage of insufflation gas through the device.

ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit.