Recall Z-0126-2021 ยท MOS Coil, Magnetic Resonance, Specialty
Invivo Corporation
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
| Date | Sep 14, 2020 |
| Status | Terminated |
| Reason | The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress. |
| Root cause | Labeling Change Control |
| Action | The firm, Philips Invivo, an " URGENT - Field Safety Notice" dated 9/14/20 to its customers. The notice described the product, problem and actions to be taken. Although the symbol on the label should not be have been included, the device poses no risk to users of these devices nor patients. Customers need take no action other than the following: -Notify all members of your staff who need to be aware of the contents of this communication. -Complete and e-mail the Acknowledgement Form included in this letter. email completed form to: DL_CHU_Invivo@philips.com -Immediate corrections are taking pl |
| Quantity | 12,764 units |
| Distribution | US Nationwide Distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OK, OH, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, and WV; and the countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Banglade |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS Mri Devices Corp., Nov 25, 2003 |
| K053017 | MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS Invivo Corporation, Nov 16, 2005 |
| K103149 | 1.5T 16-CHANNEL HAND-WRIST COIL Invivo Corporation, Jan 3, 2011 |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils Invivo Corporation, Aug 31, 2016 |