Reported Apr 20, 2016 · Terminated
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Brilliance iCT 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
- Lot codes and dates
- Model No. 728306
- S/N
267 of 267 codes
850048501085012850138501485015850168501785018850218502285023850248502585026850278502885029850328503385034850358503685037850388503985040850438504485045850468504785048850498505085051850548505585056850578505885059850608506185062850658506685067850688506985070100016100018100019100025100037100038100040100044100048
- Amount recalled
- 324 uNITS
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Medical Systems (Cleveland) Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.