Ingenuity CT scanners recalled because the patient couch may descend unexpectedly
Philips Ingenuity CT systems are recalled because the patient support table may descend unexpectedly to its lowermost position due to ball screw misalignment after a replacement. 285 units are affected.
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: 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 Ingenuity CT model numbers 728321, 728323 and 728326, with UDI-DI 00884838059498 and the serial numbers listed in the recall notice. The recall covers 285 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. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Imaging System
- Affected units
- 285
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: 728321
- UDI-DI: 00884838059498
- Serial Numbers: 310033
- 310095
- 310098
- 333020
- 333135
- 52084
- 310005
- 310019
- 310030
- 310038
- 310050
- 310057
- 310053
- 310075
- 310126
- 310009
- 310101
- 310108
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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