MR Coils The MR Coil is intended to be used in conjunction with a… — Class III medical device recall Z-0126-2021
Terminated recall by Invivo Corporation, reported 2020-10-28, distributed nationwide. The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that pro
| Recall number | Z-0126-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Gainesville, FL, United States |
| Recall initiated | 2020-09-14 |
| Classified | 2020-10-19 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2023-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 12,764 units |
| Reason classes | labeling |
| Serial numbers | 100, 1001, 1002, 1004, 1005, 101, 1010, 1013, 1014, 1017, 102, 1020, 1021, 1024, 103, 1034, 1037, 104, 1043, 1048, 1049, 105, 1050, 1051, 1053 and 475 more |
| Model numbers | 4522-150-40202, 4522-150-40362, 4535-300-54581, 4535-300-71071, 4535-300-71271, 4535-300-71281, 4535-302-77871, 4535-302-77891, 4535-302-94611, 4535-302-94612, 4535-302-94613, 4535-302-94621, 4535-302-94623, 4535-303-59931, 4535-303-59951, 4535-303-59953, 4535-303-59971, 4535-303-59973, 4535-303-60031, 4535-303-60033, 4535-303-60051, 4535-303-60053, 4535-303-60071, 4535-303-60073, 4535-303-60751 and 66 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 for recall
The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0126-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.