Reported Aug 25, 2021 · Terminated
728332 IQon Spectral CT-Computed Tomography X-ray system
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- 728332 IQon Spectral CT-Computed Tomography X-ray system
- Lot codes and dates
- Serial Number/UDI60001 (01)00884838059542(21)60001, 60005 (01)00884838059542(21)60005, 60015 (01)00884838059542(21)60015, 60017 (01)00884838059542(21)60017, 860026 (01)00884838059542(21)860026, 860035 (01)00884838059542(21)860035, 860053 (01)00884838059542(21)860053 860074 (01)00884838059542(21)860074, 860108 (01)00884838059542(21)860108, 860109 (01)00884838059542(21)860109. Software Version 4.7.7 SynchRight Option
- Amount recalled
- N/A
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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