Big Bore CT systems recalled because patient table may descend unexpectedly
Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 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 Big Bore RT model 728242 with UDI-DI 00884838095168, Brilliance CT Big Bore Oncology model 728243 and Brilliance CT Big Bore model 728244, with the serial numbers listed in the recall notice. The recall covers 33 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. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Imaging System
- Affected units
- 33
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: 728242
- UDI-DI: 00884838095168
- Serial Number: 766018. 2. Model Number: 728243
- UDI-DI: N/A
- Serial Numbers: 7179
- 7238
- 7273
- 7418
- 7467
- 7608
- 7634
- 7618
- 7801
- 7925
- 75111
- 75045
- 75119
- 75035
- 75132
- 750019
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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Similar recalls
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