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U.S. Department of Health and Human Services

Class 2 Device Recall Ziehm Vision R

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 Class 2 Device Recall Ziehm Vision Rsee related information
Date Initiated by FirmAugust 08, 2024
Date PostedDecember 02, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0577-2025
Recall Event ID 95709
510(K)NumberK061203 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductZiehm Vision R. Iterventional fluoroscopic x-ray system
Code Information UDI: EZIEZIEHMVISIONR1. Serial Numbers: 10295, 10490, 10656, 10716, 10997.
Recalling Firm/
Manufacturer		 Orthoscan, Inc.
14555 N 82nd St
Scottsdale AZ 85260-2525
For Additional Information ContactTu A Ngo
480-712-7868
Manufacturer Reason
for Recall		Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionZiehm Imaging, Inc. intends to notify the affected customers directly in the following manner: 1) Letter with return receipt requested, envelope, return, and reply to questionnaire, or E-mail contact. 2) Direct phone calls. Once contact is made and confirmed Ziehm Imaging Inc, shall provide replacement hand switch and instructions to the end user. Wired Hand switch 88036 Vl.02 will be requested to be returned by the customer/end user to Ziehm Imaging Inc. and will be subjected to be scrapped.
Quantity in Commerce5
DistributionU.S. (including Puerto Rico).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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