2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Summary
The FDA issued a Class II for 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations..
Details
Source
Device Recall
External ID
Z-1417-2023
Action Date
2023-04-26
Status
Ongoing
Category
device
Product Description
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Lot/Code Info: UDI: (01)00884838059276 2D Perfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software License Keys: 459801071511 sw key 2D Perfusion (IW) 459800240601 sw key 2D Perfusion (XV)
Quantity Affected: 549 units (75 US, 474 OUS)
Reason for Recall
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-20
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1417-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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