DR 800. Digital Radiography X-ray System.
FDA Recall Z-2738-2024 · Posted 2024-08-27
Advertisement
Recalling FirmAgfa N.V.
Recall StatusOpen, Classified
Product CodeJAA
Date Initiated2024-07-29
Product Quantity141 units
Reason for Recall
Potential for the front lever chain of the DR 800 table to fail.
Firm 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 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement