DR 800. Digital Radiography X-ray System.
Recall
- Recall Number
- Z-2738-2024
- Event Number
- 95115
- Firm
- Agfa N.V. Septestraat 27 Mortsel Belgium
- FEI Number
- 3001556265
- Product Code
- JAA
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- July 29, 2024
- Posted
- August 27, 2024
Description
DR 800. Digital Radiography X-ray System.
Potential for the front lever chain of the DR 800 table to fail.
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 within consignee organizations and forwarded to those devices were transferred to. Consignees are asked to maintain awareness of this notice until devices are corrected. Completed response forms are to be provided via email to [email protected]. Consignees with any questions are to call 1-877-777-2432 and reference PRB2001106.
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.
141 units