Philips iCT Computed Tomography System Recalled for Image Labeling Error
Philips is recalling 128 iCT computed tomography systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error that could lead to misinterpretation of medical images, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 128 units of the iCT, Model # 728306, computed tomography x-ray system. The recall is due to a software issue where, during specific cardiac step and shoot acquisitions with phase tolerance selected, images may be labeled as if phase tolerance had been applied when it had not actually been applied.
The affected systems were distributed worldwide, including the United States (including Puerto Rico), Canada, Mexico, and numerous other countries. The recall number is Z-2189-2019. Specific system serial numbers are listed in the official recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- iCT, Model # 728306, computed tomography x-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 128
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- System Serial Number 7638
- 8306
- 10015
- 85000 through 85072
- 85075 through 85184
- 100015- 100016
- 100018- 100026
- 100028
- 100030
- 100031
- 100032
- 100036 through 100079
- 100081 through 100236
- 100238
- 100240 through 100269
- 100271 through 100420
- 100423 through 100430
- 100433 through 100477
- 100480 through 100522
- 100600 through 100856
Distribution
Part of a larger recall action
This product is one of 9 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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