Philips Brilliance IQon Spectral CT recall
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Why was Philips Brilliance IQon Spectral CT recalled?
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial #s 860067, 860023
- Product
- Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
- Recalling firm
- Philips North America, LLC
- Quantity
- 2
- Distribution
- Worldwide distribution including one unit distributed to Iowa.
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)