Vials labeled for the prescriptions contained incorrect lenses
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Vials labeled for the prescriptions contained incorrect lenses
Packages labeled as containing 110mm rods may contain 100mm rods.
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Class I - Dangerous
Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens.
Class I - Dangerous
A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment.
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
O-Two Medical Technologies
Class I - Dangerous
Higher levels of nitrous oxide delivered than specification
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
Class I - Dangerous
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
SOMATOM Perspective 16 (Model 10891666)
Siemens Medical Solutions USA
Class I - Dangerous
A potential risk of unnecessary radiation exposure due to a software issue
SOMATOM Perspective (Model 10495568)
Siemens Medical Solutions USA
Class I - Dangerous
A potential risk of unnecessary radiation exposure due to a software issue
Class I - Dangerous
The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
Device may display a battery missing error.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.
Tandem Diabetes Care
Class I - Dangerous
The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.