Ziehm Solo C-arm (Orthoscan) - Device Requirements Gap (2024)
Defective hand switch can potentially initiate unintended X-ray radiation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ziehm Solo. Digital Mobile C-arm
Brand
Orthoscan, Inc.
Lot Codes / Batch Numbers
UDI: EZIEZIEHSOLO1. Serial Numbers: 50652, 51087, 51265, 52387, 52889, 53255, 54259, 54820, 54821, 54823, 54824, 54825, 54826, 55053, 55066, 55073, 55074, 55075, 55076, 55145, 55219, 55220, 55221, 55222, 55223, 55224, 55225, 55226.
Products Sold
UDI: EZIEZIEHSOLO1. Serial Numbers: 50652, 51087, 51265, 52387, 52889, 53255, 54259, 54820, 54821, 54823, 54824, 54825, 54826, 55053, 55066, 55073, 55074, 55075, 55076, 55145, 55219, 55220, 55221, 55222, 55223, 55224, 55225, 55226.
Orthoscan, Inc. is recalling Ziehm Solo. Digital Mobile C-arm due to Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026