Retiro De Equipo (Recall) de ZeroGravity Radiation Protection System

Recall

75240

Class 2

Z-0080-2017

2016-09-09

2016-10-13

Terminated

United States

2017-08-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150120

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.

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 to include the requirement to allow the cable to unwind after each use. 3. Adding additional warning labels to the system. 4. Replacing all cables in the field to ensure that any potentially stressed cable is removed. A representative from TIDI Products will be contacting you to schedule a visit from a technician to implement this corrective action. Customer Actions Cables should be carefully inspected for signs of wear or rotational tension, which will create a bend or buckle in the cable. Practitioners and medical institutions should review their routine use of the Zero-Gravity Radiation Protection System to determine if the body shield undergoes repeated rotation without allowing the cable to relax back to its normal condition. If the cable has been consistently rotated in one direction without being allowed to relax back to its normal condition or if there is any doubt about excessive rotation in one direction, TIDI recommends that practitioners and medical institutions discontinue use until such time as corrective action can be implemented by TIDI Products. If facilities continue to use their Zero-Gravity" Radiation Protection System until correction and install of the replacement cable can be performed, they should make sure that they are allowing the unit to go back to its relaxed state. Please complete and return the enclosed response for