Philips CT 6000 Patient Support Table May Descend Unexpectedly
Philips is recalling certain CT 6000 systems because the patient support table may descend unexpectedly to the lowest position due to ball screw misalignment after replacement, creating a fall risk.
What this means for you
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: This Class II medical device recall involves a risk-of-harm product (patient support table) with potential for patient injury from unexpected descent. No injuries or illnesses have been reported. Per the rubric, recalls involving risk-of-harm products without reported injury are classified as High (Score 3).
Plain-English summary
Philips North America is recalling CT 6000 systems (Model 728307) because the patient support table may descend unexpectedly to the lowermost position. This hazard can occur due to misalignment of a component (ball screw) after replacement.
The recall affects 6 units distributed worldwide, including throughout the United States and numerous international countries. The affected systems can be identified by Model Number 728307 and the serial numbers 87150, 87169, 87118, 87168, 87166, and 87164.
Facility operators should stop using affected equipment and contact Philips North America for instructions on repair or replacement. The unexpected descent of the support table poses a risk that a patient could fall or be injured.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Hazard
- mechanical-failure
- fall-risk
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 (8)
- 1. Model Number: 728307
- UDI-DI: 00884838104600
- Serial Numbers: 87150
- 87169
- 87118
- 87168
- 87166
- 87164.
Distribution
Distributed nationwide across the United States.
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