Data Foundry

Medical device recalls 2025

Philips CT systems labeled as the following: 1 — Class II medical device recall Z-2597-2025

Ongoing recall by Philips North America Llc, reported 2025-10-01, distributed nationwide. The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball

Recall numberZ-2597-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips North America Llc, Cambridge, MA, United States
Recall initiated2025-08-13
Classified2025-09-19
Reported by FDA2025-10-01
DistributedNationwide (US)
Countries outside the USAR, AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, DK, EG, ES, FR, GB, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LB, LV, MX, NL, NO, PE, PH, PL, PT, QA, RO, SE, TH, TW, VN
Quantity33 units
UPC / GTIN / UDI-DI00884838059450, 00884838095168
Serial numbers7179, 7238, 7271, 7273, 7418, 7467, 750003, 750019, 75035, 75045, 75111, 75119, 75132, 760019, 760057, 760058, 760075, 76023, 76054, 7608, 76135, 76147, 76171, 7618, 76230 and 8 more
Model numbers728242, 728243, 728244

Product

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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-2597-2025. 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.