Mobile C-arm hand switch defect may cause unintended X-ray emission
Ziehm Solo Digital Mobile C-arm devices may have hand switch defects that can cause unintended radiation emission when exposed to impacts or drops. The recalled units have been distributed in the U.S. and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving potential unintended radiation exposure from an X-ray imaging device. Although no injuries or deaths have been reported, the hazard of unintended radiation constitutes a significant risk to patients and operators, meeting the criterion for High severity.
Plain-English summary
Ziehm Imaging and manufacturer Orthoscan, Inc. are recalling 28 Ziehm Solo Digital Mobile C-arm devices distributed in the U.S. and Puerto Rico. The wired hand switch on these devices may fail when exposed to mechanical stress, such as impacts or drops.
Failure of the hand switch can irreversibly damage the switching element, which may then potentially cause the X-ray unit to emit unintended radiation, creating a risk of unexpected X-ray exposure.
The devices do not fully meet the requirements of IEC 60601-2-54 and 21 CFR 1020.32(c) regarding the performance and safety of wired hand switches. Users should verify their device's serial number against the recall notice to determine if their unit is affected.
The recalled product
- Product
- Ziehm Solo. Digital Mobile C-arm
- Manufacturer
- Orthoscan, Inc.
- Category
- Medical Device — X-ray imaging
- Hazard
- unintended-radiation
- mechanical-failure
- hand-switch-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI: EZIEZIEHSOLO1. Serial Numbers: 50652
- 51087
- 51265
- 52387
- 52889
- 53255
- 54259
- 54820
- 54821
- 54823
- 54824
- 54825
- 54826
- 55053
- 55066
- 55073
- 55074
- 55075
- 55076
- 55145
Distribution
Distribution scope not specified by the agency.
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