Recall Z-0080-2017— Contour Fabricators Inc
Class II · Terminated
Class II FDA medical device recall by Contour Fabricators Inc, initiated 2016-09-09, terminated 2017-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Zero-Gravity Radiation Protection System Radiology Personnel protective shield.. Reason: Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury..
- Recalling firm
- Contour Fabricators Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-09
- Terminated
- 2017-08-25
- Firm location
- Fenton, MI, United States
Product description
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
Reason for recall
Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.