Patient Information Center iX with Software Version recall
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient…
Why was Patient Information Center iX with Software Version 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI: (01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 Software Version Number 4.x
- Product
- Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient…
- Recalling firm
- Philips North America Llc
- Quantity
- 960 units
- Distribution
- Nationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark Finland France Germany Greece India Ireland Italy Japan Jordan Kenya Kuwait Lebanon Lithuania Netherlands Norway Poland Portugal Qatar Romania Slovakia South Africa South Korea Spain Sweden Sweden Switzerland United Kingdom Utd.Arab.Emir. Uzbekistan
- Recall date
- September 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)