Z-0647-2022Class II

Zenition 50, Model #718096

Name: Z-0647-2022 Zenition 50, Model #718096
Creator: Philips Medical Systems Nederland B.v.
Published: 2021-12-02
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2021-12-02 / Open, Classified / root cause: software

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Zenition 50, Model #718096 on 2021-12-02. FDA classified it as Class II and gives the reason as "Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used...". 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-0647-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-02
Posted: 2022-02-17
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Zenition 50, Model #718096
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On December 2, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. The Medical Device Correction includes the following instructions for the Customer: o Ensure that the wired foot switch is always connected to the system. o Immediately start using the wired foot switch or hand switch in the event the wireless foot switch loses connection. o Perform a daily check for damage and correct functioning of the hand switch and wired foot switch as described by the User Routine Checks section in your Instruction for Use. o Circulate this notice to all users of this device so that they are aware of the issue./ o Place this Medical Device Correction with the documentation of the Philips Zenition 50, Zenition 70 or Veradius Unity system. o Return the attached reply form to Philips to confirm that: 1. The Zenition 50, Zenition 70 and Veradius Unity systems wired foot switch is connected to the system 2. The users of the system have reviewed and understood this Medical Device Correction. If you need further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377.
Quantity in commerce: 16 US; 76 ROW
Distribution: Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
Product codes and lots: Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0647-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0647-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-17
Z-0648-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-17
Z-0649-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-17

Product code OWB

K183101Class IIZenition 50Philips Medical Systems Nederland B.V. / cleared 2018-12-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)