Reported May 31, 2023 · Ongoing
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Philips Headquarters Cambridge
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 HEADQUARTERS CAMBRIDGE · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Incisive CT- whole-body computed tomography (CT)
- X-Ray System Model Number728144
- Lot codes and dates
- UDI-Di(01)00884838105508(21)
- Serial Numbers
34053340923416434168341793419534200 (US)
- OUSSystem Serial Number
76 of 76 codes
34010340203406134070341073410834127341423414734157341583416134166341763417734178341803419434202500453500499500501500504500506500508500511500518500529550004550023550025550034550041550052550065550069550077550079550084550086550093550103550107550114550115550119550121550128550130550140550141550150550162550164550169550174550176550181550187550188
- Amount recalled
- 7 units US and 76 unit OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
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 Headquarters Cambridge 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.