Recall Z-0080-2017 ยท EAJ Apron, Leaded
Contour Fabricators Inc
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
| Date | Oct 13, 2016 (initiated Sep 9, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | On 9/9/2016, URGENT: MEDICAL DEVICE CORRECTION letters dated 9/8/2016 were sent to the affected consignees via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. TIDI Products is taking the following action to correct this issue: 1. Revising instructions for use to include the step to allow the cable to unwind after use and prior to storing the body shield in a locked or secured position. 2. Modifying user and staff training protocols t |
| Quantity | 447 |
| Distribution | 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.) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.