Philips CT Systems Recalled Due to Potential Oil Accumulator Bolt Failure
Philips is recalling 112 Computed Tomography X-Ray Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.
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 is classified as FDA Class II. The hazard involves a mechanical component failure (bolt failure) that could lead to equipment damage or potential injury, but no specific injuries or illnesses are reported in the source text, 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 112 units of Computed Tomography X-Ray Systems, including the Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, and GEMINI Dual models. These devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
The recall is being conducted because a bolt that attaches the oil accumulator within the gantry may fail. This failure could result in the oil accumulator detaching from the tube housing assembly within the gantry. The affected units were distributed worldwide, including in the United States and various international markets.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address this defect. No specific consumer action is required for the general public, as these are professional medical devices.
The recalled product
- Product
- Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 112
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 #: 728130
- Serial #: 8128
- 8158 & 8369. System Code #: 728256
- Serial #: 3695
- 3703
- 371 &
- 3719. System Code #: 728246
- Serial #: 3463
- 3508
- 3519
- 3548
- 3552
- 3591
- 3592
- 3593
- 3603
- 3637
- 3648
- 3654
- 3659
Distribution
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