Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
Medical device recall Z-0080-2017. Published in FDA’s Enforcement Report on Oct 19, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 19, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 447 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
447, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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-6-5ROUNDH : Zero-Gravity floor unit ZGM-6Demo : Zero-Gravity…
Every code shown here, 953 characters
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-6-5ROUNDH : Zero-Gravity floor unit ZGM-6Demo : Zero-Gravity demo floor unit ZGCM-48 : Zero-Gravity ceiling mounted monorail with 48 boom arm ZGCM-48-SPECIAL : Zero-Gravity ceiling mounted monorail with 48 boom arm with monorail extension ZG48 : Zero-Gravity 48 boom arm assembly and body shield for monorail ZGCM-66 : Zero-Gravity ceiling mounted monorail with 66 boom arm ZGCM-HSA : Zero-Gravity ceiling mounted monorail with hinged swing arm ZGCH : Zero-Gravity ceiling mounted monorail Contour track with 48 boom arm ZGCH48 : Zero-Gravity 48 boom arm assembly and body shield for Contour track ZGHSA : Zero-Gravity single point, ceiling mount with hinged swing arm ZGCSP : Zero-Gravity single point, ceiling mount with hinged swing arm 29858 : Zero-Gravity floor unit
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide. Canada. AUSTRALIA AUSTRIA BELGIUM BRUNEI CHINA FRANCE GERMANY INDA INDONESIA ISRAEL ITALY KSA MALAYSIA NETHERLANDS POLAND QATAR QUEBEC SAUDI ARABIA SINGAPORE SOUTH AFRICA TAIWAN (R.O.C.)
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 9, 2016.
- FDA classified it on Oct 13, 2016.
- FDA’s Enforcement Report published it on Oct 19, 2016.
- FDA terminated it on Aug 25, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Contour Fabricators Inc, of Fenton, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.