Philips Ingenuity CT System Recalled for Incorrect Label Rating
Philips is recalling 27 Ingenuity CT systems because the product labels do not include the correct current rating.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the rating, which falls under the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 27 units of the Ingenuity CT Computed Tomography X-ray system, Model 728326. The recall was initiated because the product label does not include the correct current rating.
The affected products were distributed worldwide, including to facilities in the United States, Canada, and various international locations. The recall covers specific government and hospital accounts, including the Department of Veterans Affairs and various medical centers.
Consumers and facility administrators should contact Philips Medical Systems for further instructions regarding the correction of the product labels.
The recalled product
- Product
- Ingenuity CT Computed Tomography X-ray system, Model 728326
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 27
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)
- 30003
- 30004
- 30008
- 30014
- 30033
- 30039
- 30040
- 30041
- 30042
- 30043
- 30044
- 300037
- 300066
- 300097
- 300151
- 300156
- 300157
- 300203
- 300204
- 300205
Distribution
Part of a larger recall action
This product is one of 6 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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