—#191571

Product

Veradius Unity, Model #718132

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K142708
Affected lot / code info: Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.