Recall Z-2738-2024 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Agfa N.V.
DR 800. Digital Radiography X-ray System.
| Date | Aug 27, 2024 (initiated Jul 29, 2024) |
| Status | Open, Classified |
| Reason | Potential for the front lever chain of the DR 800 table to fail. |
| Root cause | Device Design |
| Action | Consignees were sent an URGENT FIELD SAFETY NOTICE by email, dated 7/29/24. In the notice, consignees are asked to check the correct tightening of the floor plate fixing bolts if a high and persistent noise is heard from the device during the tilting or elevation movement of the tabletop. If the noise persists, the device must be stopped immediately in a horizontal position at the maximum height. Agfa will coordinate with consignees to schedule an inspection of affected devices and to install hardware intended to reinforce equipment before 10/15/24. The recall notification is to be shared with |
| Quantity | 141 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, KS, LA, MA, MO, NJ, NC, OH, OK, SC, VA, WV, WI; and the countries of AU, BE, BW, CA, CO, CZ, DE, ES, FR, GB, GR, IL, IN, IT, KZ, MX, PL, RS, UZ, ZA. |
| FDA record | Open on fda.gov |