CT Scanner Software Upgrade May Cause Unexpected Table Movement
Philips CT scanner software upgrade may cause the patient tabletop to move unexpectedly during scan initialization, posing collision risk to nearby operators or bystanders.
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: FDA Class II recall involving a medical device with potential for operator/bystander injury from unexpected mechanical movement. No illnesses or injuries have been reported, making this a risk-of-harm scenario.
Plain-English summary
This recall affects the PHILIPS Incisive Computed Tomography X-ray system (Model 728143) running the software upgrade from version V4.5.1.41921 to V4.5.1.41989. A total of 428 units have been distributed nationwide and internationally.
The hazard: During scan initialization, the patient tabletop may move out to the home position unexpectedly. This sudden movement creates a risk of collision with operators or bystanders positioned near the rear of the table, potentially causing injury.
Affected facilities: Any healthcare facility or diagnostic imaging center using the affected Philips CT systems with the identified serial numbers and the specified software versions is potentially affected.
What to do: Facilities operating affected systems should contact Philips North America immediately for guidance. Do not operate the affected equipment until the issue is resolved or a corrective software update is provided.
The recalled product
- Product
- PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
- Manufacturer
- Philips North America
- Affected units
- 428
Distribution
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