Reported Apr 26, 2023 · Ongoing
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Philips Medical Systems Nederland B.v.
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 MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
2D Perfusionrelease R1.0.xR1.1.xR1.2and R1.2.1
- Lot codes and dates
- UDI(01)00884838059276 2D Perfusion with
- Allura Xper or Azurion model number
722003722006722008722010722012722013722020722023722026722027 722028722029722035722038722039722058722059722064722067 722068722078722079722223722224722225722226722227 and 722228
- Software License Keys459801071511 sw key 2D Perfusion (IW) 459800240601 sw key 2D Perfusion (XV)
- Amount recalled
- 549 units (75 US, 474 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Medical Systems Nederland B.v. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.