Reported Aug 14, 2019 · Terminated
Ingenuity Core128 Model # 728323, computed tomography x-ray system
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?
- Ingenuity Core128 Model # 728323, computed tomography x-ray system
- Lot codes and dates
System Serial Number 612330016300233000683015332000 through 3205135202352028 336001 through 336038336040 through 336051336053336055 through 336061336063 through 336379336382 through 336454336701 through 33681134521876001421003-053203093205332060336039-1 3361433361473363317175_06
- Amount recalled
- 116
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
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.