Contour Zero-Gravity Radiation Protection System Recalled for Cable Failure Risk
Contour Fabricators is recalling 447 Zero-Gravity radiation protection systems because excessive cable rotation may cause the shield to fall, posing an injury risk.
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 3/5 (High).
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: The recall involves a risk-of-harm product where a falling 55-pound shield could cause injury, but the source explicitly states that no injuries or deaths have occurred, fitting the 'High' severity criteria for unreported injury risks.
Plain-English summary
Contour Fabricators Inc is recalling 447 units of the Zero-Gravity Radiation Protection System, a radiology personnel protective shield. The recall covers various models, including floor units and ceiling-mounted monorails, manufactured or distributed between June 28, 2010, and August 25, 2016. The products were distributed nationwide in the United States, as well as in Canada and numerous international locations.
The recall was initiated after two customer complaints indicated that excessive rotation of the cable in one direction without allowing it to unwind could cause the cable to break suddenly. If the cable fails, the 55-pound body shield will fall immediately. While no injuries or deaths have been reported from these specific failures, the falling shield poses a potential injury risk to the user, associated staff, and the patient.
Users should stop using the affected equipment immediately. Contour Fabricators Inc is the recalling firm and is responsible for addressing the defect.
The recalled product
- Product
- Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
- Manufacturer
- Contour Fabricators Inc
- Affected units
- 447
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 (3)
- 2010 August 25
- ceiling mount with hinged swing arm ZGCSP : Zero-Gravity single point
- ceiling mount with hinged swing arm 29858 : Zero-Gravity floor unit
Distribution
Distributed nationwide across the United States.
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