Recall Z-0126-2021— Invivo Corporation
Class III · Terminated
Class III FDA medical device recall by Invivo Corporation, initiated 2020-09-14, terminated 2023-08-14. It names 4 FDA 510(k) clearances: K162001, K103149, K053017 and 1 more. Product: 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.. Reason: The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress..
- Recalling firm
- Invivo Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-09-14
- Terminated
- 2023-08-14
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
4 on FDA's record- K162001 — 1.5T and 3.0T 16 CH GE Shoulder Coils
- K103149 — 1.5T 16-CHANNEL HAND-WRIST COIL
- K053017 — MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
- K033567 — MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
Data sourced from openFDA. This site is unofficial and independent of the FDA.