Zero-Gravity Radiation Protection System Radiology Personnel… — Class II medical device recall Z-0080-2017
Terminated recall by Contour Fabricators Inc, reported 2016-10-19, distributed nationwide. Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-cl
| Recall number | Z-0080-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Contour Fabricators Inc, Fenton, MI, United States |
| Recall initiated | 2016-09-09 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CN, DE, FR, ID, IL, IT, MY, NL, PL, QA, SA, SG, TW, ZA |
| Quantity | 447 |
| Reason classes | device malfunction |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0080-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.