Recall Z-0062-2020 ยท MOS Coil, Magnetic Resonance, Specialty
GE Healthcare, LLC
AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.
| Date | Mar 19, 2019 |
| Status | Terminated |
| Reason | The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected. |
| Root cause | Device Design |
| Action | The firm hand delivered the notices beginning on 03/19/2019. The notices described the separation of the outer seam and requested that the consignee check each coil component for tears or damage, and to discontinue use of product if product is suspected of not being in good condition. The affected products will be replaced. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative |
| Quantity | 22 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172695 | AIR Anterior Array, AIR Posterior Array Ge Healthcare Coils (Usa Instruments, Inc.), Nov 22, 2017 |