Siemens Uroskop Access Fluoroscopic X-Ray System Recalled for Table Fall Hazard
Siemens is recalling five Uroskop Access fluoroscopic x-ray systems because the table motor may disconnect, causing the table to fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where the table assembly may fall, posing a risk of significant injury to patients or personnel, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling five units of the Uroskop Access fluoroscopic, image intensified x-ray system. The recall involves model number 5756130 with serial numbers 6076, 6078, 6080, 6081, and 6082.
The recall was initiated because Siemens discovered a possible hazard to patients or hospital personnel when tilting the system. Specifically, when tilting the table, the motor may become disconnected, which could cause the entire table assembly to fall to the floor.
The affected units were distributed nationwide in the United States, including the states of Indiana, Michigan, Mississippi, Tennessee, and Texas. The source text does not specify instructions for consumers or affected facilities.
The recalled product
- Product
- Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 5
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 (5)
- Model number 5756130 -- serial numbers 6076
- 6078
- 6080
- 6081
- and 6082.
Distribution
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