Philips CT Systems Recalled for Patient Table Brake Malfunction
Philips is recalling 4,797 CT systems because a vertical brake malfunction caused an unexpected downward movement of the patient table.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a mechanical defect in a medical device that caused an unexpected movement of a patient, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 4,797 units of Brilliance, iCT, Ingenuity CT, and MX8000 Dual Computed Tomography (CT) X-Ray Systems. The recall affects systems distributed nationwide and worldwide.
The recall was initiated after Philips received field reports that the patient table on a system experienced an unexpected downward movement while a patient was on the table. Philips determined that the cause of this movement was a malfunction of the vertical brake.
Affected units are identified by specific system codes and serial numbers listed in the official recall documentation. Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect and ensure patient safety.
The recalled product
- Product
- Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 4,797
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)
- System Code #728256
- Serial #: 3001
- 3016
- 3019
- 3020
- 3025
- 3026
- 3030
- 3057
- 3058
- 3060
- 3071
- 3073
- 3074
- 3076
- 3080
- 3090
- 3095
- 3108
- 3114
Distribution
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