Philips Ingenuity Core 128 CT Scanner Recall for Fastener Torque Issues
Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.
What this means for you
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 where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling three units of the Ingenuity Core 128 CT scanner (Code 728323). The recall was initiated because the manufacturer identified that certain fasteners on these devices cannot be confirmed to have been torqued according to specification.
The affected units were distributed worldwide, including in the United States, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and the United Kingdom. In the US, four units were distributed, one of which was to a military account, while 14 foreign accounts received the product. The specific serial numbers involved are 320394, 320395, and 336286.
If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 3
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 (6)
- Code 728323
- SN # 320394
- UDI: (01)00884838059474(21)320394
- 320395
- UDI: (01)00884838059474(21)320395
- and 336286.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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