GE Healthcare MR superconducting magnets — Class II medical device recall Z-0603-2022

Ongoing recall by GE Healthcare, LLC, reported 2022-02-16, distributed nationwide. The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the vent

Recall number	`Z-0603-2022`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	GE Healthcare, LLC, Waukesha, WI, United States
Recall initiated	2021-12-23
Classified	2022-02-09
Reported by FDA	2022-02-16
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA
Quantity	17,228 devices

Product

GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.

Reason for recall

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

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-0603-2022. 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.