SENSE XL TORSO COIL 3 — Class I medical device recall Z-2164-2024
Ongoing recall by Philips North America Llc, reported 2024-07-03, distributed nationwide. Potential for coils to heat up and harm patients (burn).
| Recall number | Z-2164-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2024-06-05 |
| Classified | 2024-06-27 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, KY, LB, LK, LT, MA, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, RO, RS, SA, SE, SK, TH, TW, VE, VN, ZA |
| Quantity | 307 units |
| UPC / GTIN / UDI-DI | 00453567394943 |
| Serial numbers | 0141R3, 0172R3, 0174R3, 0189R3, 0260R3, 0265R3, 0285R3, 0358R3, 100, 102, 103, 104, 105, 107, 108, 109, 110, 112, 116, 116R3, 117, 121, 122, 123, 124 and 345 more |
| Model numbers | 453567394941, 453567394942, 453567394943, 453567394945, 459801593182, 989603050641, 989603050642 |
Product
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
Reason for recall
Potential for coils to heat up and harm patients (burn).
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-2164-2024. 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.