Summary
The FDA issued a Class II for Ziehm Vision FD. Interventional fluoroscopic x-ray system by Orthoscan, Inc.. Reason: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of.
Details
Source
Device Recall
External ID
Z-0576-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
Ziehm Vision FD. Interventional fluoroscopic x-ray system
Lot/Code Info: UDI: EZIEZIEHMVISIONFD1651 Serial Numbers: 93412, 93443, 93451, 93452, 93461, 93483, 93485, 93486, 93503, 93619, 93620, 93621. 93622 93623 93628 93629 93660 93661 93662 93626 93625 93627
Quantity Affected: 22
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.
Distribution
U.S. (including Puerto Rico).
Type: FDA Mandated
Recall Initiated: 2024-08-08
Company
Scottsdale, AZ
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 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Orthoscan, Inc. has 8 FDA actions in our database, including 7 recalls and 1 clearance.
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 (Orthoscan, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orthoscan, Inc. have FDA actions?
Orthoscan, Inc. has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0576-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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