Z-0578-2025Class II

Ziehm Vision RFD. Interventional fluoroscopic x-ray system

Name: Z-0578-2025 Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Creator: Orthoscan, Inc.
Published: 2024-08-08
License: https://open.fda.gov/license/

Orthoscan, Inc. / initiated 2024-08-08 / Open, Classified / root cause: manufacturing process

FDA source

Orthoscan, Inc. began a recall of Ziehm Vision RFD. Interventional fluoroscopic x-ray system on 2024-08-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0578-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-08
Posted: 2024-12-02
Recalling firm: Orthoscan, Inc.
Product: Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Product code: OWB Interventional 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.
Root cause tag: manufacturing process
FDA root cause: Radiation Control for Health and Safety Act
Action: Ziehm 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 commerce: 30
Distribution: U.S. (including Puerto Rico).
Product codes and lots: UDI: EZIEZIEHMVISIONRFD1. Serial Numbers: 20048, 20240, 23805, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375, 23376, 23377, 23378, 23379, 23380, 23381, 23382, 23412, 23452, 23460, 23461, 23462, 23463, 23506, 23536, 23721, 23737, 23738, 23739.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0578-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0573-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-02
Z-0574-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-02
Z-0575-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-02
Z-0576-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-02
Z-0577-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-02
Z-0578-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-02
Z-0579-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-02

Product code OWB

K240099Class IIZiehm Vision RFDZiehm Imaging GmbH / cleared 2024-02-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)