Philips CT System Recalled for Incorrect Label Rating
Philips is recalling two Ingenuity Core 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 current rating.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the Ingenuity Core Computed Tomography X-ray system, Model 728321. 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 source text lists specific government and Canadian accounts, as well as a list of countries where the products were shipped.
Consumers and facility operators should contact the recalling firm for instructions on how to correct the labeling issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Ingenuity Core Computed Tomography X-ray system, Model 728321
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 2
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 (2)
- 310160
- 310234
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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