Diagnostic imaging system recalled due to ceiling and wall collision risk
Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.
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: FDA Class II recall involving a potential collision hazard that could cause serious injury to patients and staff. No injuries have been reported in the source material; therefore, this is classified as a risk-of-harm product without reported injury, meeting the criteria for High severity.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Uroskop Omnia Max diagnostic imaging systems with software versions VE10 and VF11. These radiographic and fluoroscopic imaging systems are used in medical facilities and were distributed nationwide in the United States.
The recall addresses a potential collision hazard. The system's room configuration parameters are set to default values, which may cause the imaging equipment to collide with ceilings, walls, or nearby objects during operation. Such collisions could result in serious injury to healthcare staff or patients in the vicinity of the equipment.
An initial recall involved 7 affected units. The recall was expanded on February 24, 2023, to include 215 total units. Affected devices can be identified using the Universal Device Identifier (UDI: 4056869008981) and the specific serial numbers provided in the recall notices.
The recalled product
- Product
- Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- collision
- impact-injury
Distribution
Distributed nationwide across the United States.
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