Philips CT Scanners Recalled for Disengaged Service Latch
Philips Medical Systems is recalling 6,839 CT scanners worldwide because a service latch may disengage, causing the table top to become free-floating.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a medical device that could lead to injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 6,839 Computed Tomography (CT) X-ray systems worldwide. The affected models include the Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and MX8000 Dual v. EXP scanners.
The recall was initiated after a customer reported that the table top had become free-floating. A Field Service Engineer confirmed that the service latch had become disengaged. This defect could potentially allow the table top to move unexpectedly.
The affected units were distributed in the US nationwide (including PR and DC) and in numerous countries worldwide. Specific serial numbers for each model are listed in the official recall documentation. Users should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
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)
- Brilliance CT 6: M/N: 728256
- S/N: 3001
- 3002
- 3005
- 3007
- 3014
- 3016
- 3019-3021
- 3025
- 3026
- 3028
- 3032-3036
- 3045
- 3046
- 3049
- 3051
- 3052
- 3057
- 3058
- 3060
Distribution
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