Philips CT Scanner Recall Due to Tabletop Movement Failure
Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.
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 prevent necessary patient positioning during a scan. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 1,363 units of Philips Healthcare System X-ray Tomography Computed scanners. The affected models include the Brilliance iCT SP, Brilliance iCT, Brilliance 64, Brilliance 40, Brilliance 16, Brilliance 16P, Brilliance 10, Brilliance 6, and Brilliance Big Bore.
The recall was initiated because it was discovered that the patient support tabletop may fail to move in the horizontal direction when commanded to do so during CT scans. This issue is attributed to a potential mechanical linkage failure.
The affected units were distributed nationwide in the United States to the states of AZ, NY, GA, UT, TN, TX, AR, NV, IL, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL, and IA. Healthcare facilities should contact Philips for further instructions on how to address this defect.
The recalled product
- Product
- Philips Healthcare System X-ray Tomography Computed :
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 1,363
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 (9)
- Brilliance iCT SP
- Brilliance iCT
- Brilliance 64
- Brilliance 40
- Brilliance 16
- Brilliance 16P
- Brilliance 10
- Brilliance 6
- Brilliance Big Bore.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Electronics North America Corporation 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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