Philips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
Philips is recalling IQon Spectral CT systems because the clinical scan may not start automatically after Bolus Tracking, requiring manual triggering and potentially causing extra radiation exposure.
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: This is an FDA Class II recall involving a device malfunction that could lead to patient rescan and additional radiation exposure, with no reported injuries in the source. It fits the High rubric category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems is recalling IQon Spectral CT systems and IQon Spectral CT Upgrades. The recall covers 42 units distributed nationwide in the US, including Puerto Rico. Affected product identifiers include FCO72800812, FCO72800814, 728331, 728332, and DI (01)00884838059542.
During a clinical CT scan, the scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may also occur. This can result in the clinical acquisition being inadequate for diagnosis, which may require the patient to be rescanned and receive additional radiation.
Healthcare facilities using the affected IQon Spectral CT systems are the affected population. The FDA has classified this recall as Class II. The notice does not report any injuries and does not list specific remediation steps; users should consult the FDA recall notice and contact Philips Medical Systems for further guidance.
The recalled product
- Product
- IQon Spectral CT IQon Spectral CT Upgrades
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Affected units
- 42
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 (3)
- FCO72800812
- FCO72800814 728331 728332
- DI (01)00884838059542
Distribution
Part of a larger recall action
This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS 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.
See all 3 products in this recall →Related recalls
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