Philips Brilliance iCT Computed Tomography System Recalled for Labeling Error
Philips Medical Systems is recalling 67 Brilliance iCT Computed Tomography X-ray 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 and labeling error (missing current rating) rather than a functional safety defect.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 67 units of the Brilliance iCT Computed Tomography X-ray system, Model 728306. The recall was initiated because the product label does not include the correct current rating.
The affected products were distributed worldwide, including to 15 U.S. states, five government accounts, five Canadian accounts, and 26 other countries. The recall is classified as Class III by the U.S. Food and Drug Administration.
No specific consumer actions are detailed in the source text beyond the recall notification. The hazard is limited to a documentation and labeling discrepancy regarding the product's current rating.
The recalled product
- Product
- Brilliance iCT Computed Tomography X-ray system, Model 728306
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 67
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)
- 85003
- 85004
- 85010
- 85033
- 85035
- 85038
- 85043
- 85054
- 85060
- 100054
- 100064
- 100093
- 100113
- 100119
- 100134
- 100180
- 100181
- 100185
- 100280
- 100304
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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