Philips IQon CT systems patient support tables may descend unexpectedly
Philips IQon Spectral CT systems' patient support tables may descend unexpectedly to the lowermost position due to ball screw misalignment after component replacement.
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: FDA Class II recall with a mechanical hazard that poses risk of injury to patients or staff, but with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High severity.
Plain-English summary
Philips is recalling 81 IQon Spectral CT systems, specifically Model 728332, that were distributed worldwide, including throughout the United States.
The patient support table (couch) on these systems may descend unexpectedly to the lowermost position due to a ball screw component misalignment. This condition can occur following a component replacement.
An unexpected descent could potentially cause injury to patients or healthcare personnel positioned near or on the table. No injuries have been reported in connection with this issue.
Philips has initiated this recall to address the safety hazard. Healthcare facilities with affected systems should contact Philips for further instructions.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
- Manufacturer
- Philips North America Llc
- Hazard
- patient-table-descent
- mechanical-failure
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: 728332
- UDI-DI: 00884838059542
- Serial Numbers: 860088
- 860023
- 860077
- 860086
- 60019
- 860152
- 860215
- 60031
- 60123
- 60129
- 60152
- 860011
- 860049
- 860019
- 860008
- 860030
- 860025
- 860009
Distribution
Distributed nationwide across the United States.
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