Reported Oct 19, 2016 · Terminated
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
Contour Fabricators Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Contour Fabricators Inc · 14241 N Fenton Rd · Fenton, MI · 48430-1541
Is this the product you have?
- Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
- Lot codes and dates
- All serial numbers for all models listed below manufactured/distributed between June 28, 2010 August 25, 2016. Part No. : Description ZGM-6-.5H :
- Zero-Gravity floor unit ZGM-6-5ROUNDHZero-Gravity
- floor unit ZGM-6DemoZero-Gravity
- demo floor unit ZGCM-48Zero-Gravity ceiling mounted monorail with 48
- boom arm ZGCM-48-SPECIALZero-Gravity ceiling mounted monorail with 48
- boom arm with monorail extension ZG48Zero-Gravity 48 boom arm assembly
- and body shield for monorail ZGCM-66Zero-Gravity ceiling mounted monorail with 66
- boom arm ZGCM-HSAZero-Gravity ceiling mounted
- monorail with hinged swing arm ZGCHZero-Gravity ceiling mounted monorail Contour track with 48
- boom arm ZGCH48Zero-Gravity 48 boom arm assembly
- and body shield for Contour track ZGHSAZero-Gravity single point, ceiling
- mount with hinged swing arm ZGCSPZero-Gravity single point, ceiling
- mount with hinged swing arm 29858Zero-Gravity floor unit
- Amount recalled
- 447
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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