Philips CT Scanners Recalled for Patient Selection and Scan Safety Issues
Philips Medical Systems is recalling 50 CT scanners due to a software defect that can cause incorrect patient names to appear on exam pages and allow clinical scans to start during anti-virus scans.
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 involves a medical device with a defect that can lead to incorrect patient identification and potential interference with clinical scans, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 50 units of Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners. These are whole-body Computed Tomography X-ray systems used to produce cross-sectional images of the body. The recall is due to a software defect in the user interface.
The defect occurs when an operator selects a patient name from the worklist using a mouse and then selects a different patient name using the keyboard. In this scenario, the patient name that populates the exam information page is the one selected with the mouse, not the keyboard. Additionally, it is possible to begin a normal clinical scan while an anti-virus scan is running, which may interfere with the clinical procedure.
The affected units were distributed nationwide, including in Arkansas, Arizona, Delaware, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Mississippi, Montana, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Vermont, West Virginia, and Wyoming. Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue.
The recalled product
- Product
- Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 50
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)
- The following codes are affected by this recall:System Code #728231
- Serial #: 9654
- 91003
- 95130
- 95157
- 95504 System Code #728326
- Serial #: 32000
- 300003
- 300004
- 300005
- 300010
- 300011
- 300012
- 300013
- 300014
- 300015
- 300018
- 300027
- 300041
- 300053
Distribution
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