Field Upgrade Kits: P/N 5451208 RIU — Class II medical device recall Z-2279-2023

Ongoing recall by GE OEC Medical Systems, Inc, reported 2023-08-09, distributed nationwide. Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the sys

Recall number	`Z-2279-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	GE OEC Medical Systems, Inc, Salt Lake City, UT, United States
Recall initiated	2023-05-15
Classified	2023-07-31
Reported by FDA	2023-08-09
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AU, BD, BE, BG, BO, BR, CA, CH, CL, CO, CZ, DE, DO, DZ, EC, EE, EG, ES, FR, GB, HK, ID, IE, IL, IN, IQ, IT, JM, JP, KR, MA, MX, MY, NG, NP, NZ, PE, PL, PT, PY, RO, RU, SG, TH, TT, TW, UY, VN
Quantity	16
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`00840682114301`, `00840682114349`

Product

Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

Reason for recall

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

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-2279-2023. 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.