Reported Sep 26, 2012 · Terminated
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body…
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 Road · Cleveland, OH · 44143-2131
Is this the product you have?
- MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
- Lot codes and dates
System Code #728131Serial #: EP16E090001-EP16E090004EP16E090006-EP16E090015EP16E100001- EP16E100004EP16E100006EP16E100008- EP16E100063EP16E100067EP16E100069- EP16E100113EP16E110001- EP16E110065EP16E110067-EP16E110070EP16E110074-EP16E110075EP16E110077-EP16E110078EP16E110080EP16E110083- EP16E110085EP16E110088- EP16E110112EP16E110115- EP16E110119EP16E120001- EP16E120014EP16E120016EP16EB110003- EP16ER100007EP16ER110003EP16ER110006P16C080001P16C080002P16C090001P16C100001-P16C100015P16C100017P16C100018P16C110001- P16C110008P16C110011-P16C110037P16C120001-P16C120003P16C120006P16C120007P16E080005P16E080007P16E080008P16E080012P16E090002-P16E090021P16E090024-P16E090028P16E100002P16EF80010P16EM08003and P16EM09002-P16EM09004. System Code #728132Serial #: EP16E100005EP16E100007EP16E110066EP16ER100003-EP16ER100005EP16ER100008EP16ER110004EP16ER110005and EP16ER110007-EP16ER110024
- Amount recalled
- 328 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
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.