Data Foundry

Medical device recalls 2025

Philips CT systems labeled as the following: 1 — Class II medical device recall Z-2596-2025

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-2596-2025
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
Quantity73 units
Serial numbers260046, 260074, 30117, 3290, 3347, 3499, 3578, 3664, 50017, 50028, 50129, 50219, 5029, 5286, 5305, 5307, 5388, 5411, 5412, 5422, 5424, 5497, 5504, 5515, 5584 and 48 more
Model numbers728240, 728246, 728256

Product

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.

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-2596-2025. 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.