Reported Aug 14, 2019 · Terminated
Ingenuity CT, Model # 728326, 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 CT, Model # 728326, computed tomography x-ray system
- Lot codes and dates
System Serial Number 10474300033000530006 through 3000930011 through 3001530017 through 3005030053-3005430056520355204952051100367 122276300003 Through 300005300010 through 300012300014300016 through 300066300068 through 300135300136 through 300145300147 through 300151300153- 300154300156 through 300166300200 through 30026332012733605333900133900733900833900930004-1336124
- Amount recalled
- 92
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.
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