Philips CT Systems Recalled for Potential Patient Support Movement
Philips is recalling 126 CT systems because a damaged foot switch cover may cause the patient support to move unexpectedly.
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 risk-of-harm product (patient support movement) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 126 units of Brilliance 6, 10, 16, 40, 64, and CT Big Bore Computed Tomography X-Ray Systems. The recall is due to a potential safety hazard where the patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
The affected devices are distributed worldwide, including in the United States and various international markets. The recall includes specific system codes and serial numbers, which are detailed in the official FDA recall notice. No illnesses or injuries have been reported in connection with this recall.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the issue. Consumers and patients should consult their healthcare provider if they have concerns about their recent CT scans.
The recalled product
- Product
- The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 126
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 # 728243
- Serial #s: 7392
- 7394
- 7399
- 7405
- 7406
- 7429
- 7433
- 7440
- 7457
- 7465
- 7469
- 7479
- 7481
- 7487
- 7488
- 7491
- 7502
- 7506
- 7507
Distribution
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