Reported Aug 5, 2015 · Terminated
Computed Tomography X-ray Systems Brilliance iCT SP. 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?
- Computed Tomography X-ray Systems Brilliance iCT SP. 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 #728311Serial #s: 200047 & 200121
- Amount recalled
- 2 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
5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
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.