Philips CT Scanner Recall for Incorrect Product Label Rating
Philips is recalling 15 Ingenuity Core 128 CT scanners 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a labeling error regarding the product rating.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 15 units of the Ingenuity Core 128 Computed Tomography X-ray system, Model 728323. The recall was initiated because the product label does not include the correct current rating.
The affected units were distributed worldwide, including to facilities in the United States, Canada, and various international locations. The recall covers specific serial codes associated with the affected equipment.
This recall is classified as Class III by the FDA, indicating that the use of the product is not likely to cause adverse health consequences. Users should contact the manufacturer for further instructions regarding the labeling correction.
The recalled product
- Product
- Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 15
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 (15)
- 32012
- 32057
- 320202
- 320207
- 320227
- 320232
- 336011
- 336034
- 336076
- 336100
- 336129
- 336133
- 336142
- 36145
- 336163
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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