Brilliance CT 40 and 64 channel systems recalled over unexpected couch descent
Philips Brilliance CT 40 Channel, Brilliance CT 64 Channel and Ingenuity Flex systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 181 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a patient table that drops unexpectedly is a potential harm and no injuries are reported.
Plain-English summary
Philips CT systems are being recalled under Brilliance CT 40 Channel model 728235, Brilliance CT 64 Channel model 728231 and Ingenuity Flex model 728317, with the serial numbers listed in the recall notice. The recall covers 181 units distributed nationwide in the United States and in many other countries.
The patient support table, or couch, may descend unexpectedly to the lowermost position because of a component misalignment involving the ball screw after a replacement. The FDA classified the action as Class II.
Imaging sites operating these systems should follow the manufacturer's instructions for inspection and correction.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Imaging System
- Affected units
- 181
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)
- 1. Model Number: 728235
- UDI-DI: N/A
- Serial Numbers: 9223
- 9115
- 9225
- 29144. 2. Model Number: 728231
- Serial Numbers: 95647
- 9194
- 95341
- 95234
- 10051
- 95488
- 10098
- 95695
- 10309
- 95217
- 95698
- 10443
- 10544
- 10531
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Philips North America Llc 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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