Philips CT Scanner Recall Due to Potential 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, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 1,363 units of the Philips Healthcare System X-ray Tomography Computed Tomography (CT) scanners. The affected models include the Ingenuity CT, Ingenuity Core, and Ingenuity Core 128. These devices were distributed nationwide to 35 states, including Arizona, New York, Georgia, and California.
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 source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and consumers who possess these specific CT scanner models should contact Philips Electronics North America Corporation for further instructions on how to address the mechanical issue. The recall number for this action is Z-0376-2017.
The recalled product
- Product
- Philips Healthcare System X-ray Tomography Computed :
- Manufacturer
- Philips Electronics North America Corporation
- 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 (3)
- Ingenuity CT
- Ingenuity Core
- Ingenuity Core 128.
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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