Ingenia 1 — Class II medical device recall Z-2411-2021

Completed recall by Philips North America Llc, reported 2021-09-15, distributed nationwide. When using manual mode, the tabletop may not completely move in or out and result in potential delay in patien

Recall number	`Z-2411-2021`
Product type	Medical device
Classification	Class II
Status	Completed
Voluntary or mandated	Voluntary
Recalling firm	Philips North America Llc, Cambridge, MA, United States
Recall initiated	2021-08-11
Classified	2021-09-03
Reported by FDA	2021-09-15
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, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA
UPC / GTIN / UDI-DI	`00884838055322`
Model numbers	`41146`, `781341`, `781396`

Product

Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

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-2411-2021. 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.