Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
ISee Ortho-K Lens
PARAGON VISION SCIENCES
Class I - Dangerous
Manufactured lenses are not covered by existing FDA approval
Class I - Dangerous
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Allura Xper series
Philips Medical Systems Nederland B.V.
Class I - Dangerous
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Class I - Dangerous
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
ZVU Functional GI Software, REF: ZVU-3
Diversatek Healthcare
Class I - Dangerous
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Azurion
Philips Medical Systems Nederland B.V.
Class I - Dangerous
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Fargo Ortho-K Lens
PARAGON VISION SCIENCES
Class I - Dangerous
Manufactured lenses are not covered by existing FDA approval
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Philips Ultrasound
Class I - Dangerous
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
Class I - Dangerous
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
MultiDiagnost-Eleva
Philips Medical Systems Nederland B.V.
Class I - Dangerous
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Class I - Dangerous
Sterility of device may be compromised due to breach of the chevron seal of the packaging
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Aesculap Implant Systems
Class I - Dangerous
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30Âŋ neuroendoscope, a portion of the visual field is obscured.
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Siemens Healthcare Diagnostics
Class I - Dangerous
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
Class I - Dangerous
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.