Philips CT systems patient support table may descend unexpectedly
Philips Brilliance iCT SP CT systems (Model 728311) may experience unexpected descent of the patient support table due to ball screw misalignment after component replacement. Affected units should be serviced immediately.
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 is a risk-of-harm product where injury has not yet been reported. The patient support table malfunction could cause harm during imaging procedures, matching the High severity criterion for medical devices with potential injury risk but no documented incidents.
Plain-English summary
Philips is recalling 14 units of its Brilliance iCT SP CT imaging systems (Model 728311) due to a potential malfunction in the patient support table (couch). After component replacement, the ball screw—which controls the table's vertical position—may become misaligned, causing the table to descend unexpectedly to its lowest position.
These systems have been distributed worldwide, including throughout the United States and across multiple countries in Europe, Asia, South America, the Middle East, and Africa. The affected units are identified by specific serial numbers: 200016, 200024, 200211, 200041, 200030, 200060, 200048, 200069, 200098, 200097, 200112, 200136, 200200, and 200209.
Healthcare facilities and patients using these systems should contact Philips immediately for service. An unexpected descent of the table during imaging or patient positioning poses a potential injury risk.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
- Manufacturer
- Philips North America Llc
- Hazard
- equipment-malfunction
- descent-hazard
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 (16)
- 1. Model Number: 728311
- UDI-DI: N/A
- Serial Number: 200016
- 200024
- 200211
- 200041
- 200030
- 200060
- 200048
- 200069
- 200098
- 200097
- 200112
- 200136
- 200200
- 200209.
Distribution
Distributed nationwide across the United States.
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