Philips Big Bore Oncology Scanner Recalled for Incorrect Screw Material
Philips is recalling 47 Big Bore Oncology scanners because the socket head cap screws in the Z-Axis Adjustment Plate were made of stainless steel instead of the specified alloy steel.
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 2/5 (Moderate).
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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a material specification deviation without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 47 units of the Big Bore Oncology tomography X-ray system scanner, model number 728243. The recall is due to a material defect in the Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate. These screws were found to be made of stainless steel rather than the specified alloy steel.
The affected units were distributed worldwide to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and the United Kingdom. The recall covers specific serial numbers ranging from 75002 to 75105, as well as 750111 and 750114.
Healthcare facilities and users should contact Philips Medical Systems for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 47
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)
- Big Bore Oncology System Code 728243
- Serial numbers: 75002
- 75003
- 75004
- 75005
- 75006
- 75007
- 75008
- 75009
- 75010
- 75011
- 75012
- 75014
- 75015
- 75016
- 75017
- 75018
- 75019
- 75020
- 75021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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