Reported Aug 14, 2019 · Terminated
iCT, Model # 728306, 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?
- iCT, Model # 728306, computed tomography x-ray system
- Lot codes and dates
System Serial Number 763883061001585000 through 8507285075 through 85184100015- 100016100018- 100026100028100030100031100032100036 through 100079100081 through 100236100238100240 through 100269100271 through 100420100423 through 100430100433 through 100477100480 through 100522100600 through 100856100858200004- 200005 100155100184/80924239*0084263-067203_117621_02100272
- Amount recalled
- 128
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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