Data Foundry

Medical device recalls 2015

Brilliance CT 16 Water — Class II medical device recall Z-1652-2015

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-06-03. The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpec

Recall numberZ-1652-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated2015-03-16
Classified2015-05-22
Reported by FDA2015-06-03
Terminated2017-02-22
Countries outside the USCN
Quantity153 units
Serial numbers3500

Product

Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

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-1652-2015. 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.