Philips CT Scanner Recall for Obscured Machine Name Label
Philips is recalling 32 CT scanners because the machine name label is obscured in TumorLOC Basic Mode, preventing users from viewing or changing the name.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The issue is a user interface defect that obscures a label, which is a documentation or cosmetic issue unlikely to cause adverse health consequences.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 32 units of the Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology). The recall involves specific model numbers distributed worldwide, including in the United States and various international markets.
The recall is due to a software interface issue where the Machine Name label and field are covered by controls when TumorLOC is in Basic Mode and Set Vertical Laser is set to Yes. This obscures the machine name, making it impossible for users to view or change it.
Healthcare facilities that have purchased or received these specific units should contact Philips Medical Systems for further instructions on resolving the issue.
The recalled product
- Product
- Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 32
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)
- Model #: 728243
- 7133
- 7170
- 7225
- 7262
- 7265
- 7701
- 7706
- 7779
- 7788
- 7792
- 7797
- 7802
- 7805
- 7806
- 7807
- 7808
- 7810
- 7811
- 7812
Distribution
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