Philips CT Scanner Recall Due to Potential Cover Cracking Hazard
Philips is recalling three Brilliance CT Big Bore Oncology scanners because a thinner plastic cover may crack and cause injury to patients or staff.
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 is classified as FDA Class II and involves a risk of physical injury from a cracking component, but the source text does not report any actual injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling three units of the Brilliance CT Big Bore Oncology, model #728243. These devices are intended to produce cross-sectional images of the body. The recall is identified by the code 921216.
The recall was initiated because a supplier design change resulted in the use of thinner plastic for the device covers. This thinner plastic may crack, which poses a risk of injury to patients, operators, bystanders, or service personnel.
The affected units were distributed in China, Denmark, Germany, Hungary, Italy, the Philippines, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. Users of these devices should contact Philips Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- 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 (1)
- 921216
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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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