Potential that product has not reached complete sterilization,
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow International
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow International
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow International
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Alcon Research Laboratories
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Arrow International
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow International
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow International
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Incorrect expiration being entered for one lot.
Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.