Reported Sep 27, 2023 · Ongoing
Patient Information Center iX with Software Version Number 4.x in the following
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?
Patient Information Center iX with Software Version Number 4.x in the following
3 of 3 products
| Model / number | Product as published |
|---|---|
(2) | Number: 866389 |
(3) | Number: 866390 |
(4) | Number: 867093 |
- Lot codes and dates
- UDI(01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 Software Version Number 4.x
- Amount recalled
- 960 units
Where it was sold
- Nationwide
Why it was recalled
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients
This product could cause temporary or reversible health problems — stop using it.
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