Recall Z-0579-2025— Orthoscan, Inc.
Class II · Ongoing
Class II FDA medical device recall by Orthoscan, Inc., initiated 2024-08-08. It names one FDA 510(k) clearance: K231701. Product: Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system. Reason: 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..
- Recalling firm
- Orthoscan, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-08
- Firm location
- Scottsdale, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.