Z-1583-2025Class II

Zenition 70. The device is to be used in health care facilities both inside and outside the operating room...

Name: Z-1583-2025 Zenition 70. The device is to be used in health care facilities both inside and outside the operating room...
Creator: Philips Medical Systems Nederland B.V.
Published: 2023-07-20
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-07-20 / Open, Classified / root cause: software

FDA source

Philips Medical Systems Nederland B.V. began a recall of 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... on 2023-07-20. FDA classified it as Class II and gives the reason as "Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1583-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-20
Posted: 2025-04-21
Recalling firm: Philips Medical Systems Nederland B.V.
Product: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA root cause: Software design
Action: Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the following actions that should be taken to prevent risks to patients: Keep the Electronic Product Radiation Correction letter with the documentation of the system. Where possible, place the Wireless Foot Switch within a 3 meter range from the C-arm stand to minimize as much as possible the potential delay of 72 milliseconds. Circulate this Electronic Product Radiation Correction letter to all users of the system so that they are aware of the issue. Philips will contact customers to schedule a visit to arrange for a Field Service Engineer visit to update the Software free of charge. (Philips reference 2024-IGT-PUN-007).
Quantity in commerce: 12 systems
Distribution: US Nationwide distribution
Product codes and lots: Zenition 70

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1583-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1583-2025	Class II	Ongoing	FDA Mandated	2025-04-30	2025-04-21

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)