Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as w
Summary
The FDA issued a Class II for Zenition 70. The device is to be used in health care facilities both inside and by Philips Medical Systems Nederland B.V.. Reason: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foo.
Details
Source
Device Recall
External ID
Z-1583-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Lot/Code Info: Zenition 70
Quantity Affected: 12 systems
Reason for Recall
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Distribution
US Nationwide distribution
Type: FDA Mandated
Recall Initiated: 2023-07-20
Company
Eindhoven, N/A
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 193 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-1583-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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