Philips Recalls Head Holders for Ingenuity Core 128 CT Systems
Philips Medical Systems is recalling 55 head holders shipped with Ingenuity Core 128 CT systems because they were not qualified for use on this specific model.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, indicating a theoretical or low-risk hazard consistent with a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 55 head holders that were shipped with Ingenuity Core 128 Computed Tomography (CT) X-ray systems. The recall is due to the fact that these specific head holders were released for use with other CT systems but had not yet been qualified for use on the Ingenuity Core 128 model.
The affected head holders have Model Number 4535 671 11331. They were distributed worldwide to various U.S. states and international countries. The recall involves specific serial numbers for the Ingenuity Core 128 systems, ranging from 300068 to 320059, as well as EP16E110092.
Healthcare facilities and consumers should stop using the affected head holders with the Ingenuity Core 128 CT systems. Philips Medical Systems is the recalling firm responsible for managing this recall.
The recalled product
- Product
- Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 55
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)
- Head Holder M/N 4535 671 11331. Ingenuity Core 128 - M/N 728323
- Serial #s: 300068
- 320003
- 320004
- 320005
- 320006
- 320007
- 320008
- 320009
- 320010
- 320011
- 320013
- 320014
- 320015
- 320017
- 320018
- 320019
- 320020
- 320021
- 320022
Distribution
Part of a larger recall action
This product is one of 3 recalled by Philips Medical Systems (Cleveland) Inc 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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