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Terminated

DX-D600 - DXD Imaging Package

FDA Recall Z-1738-2017 · Posted 2017-04-05

Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeKPR
Date Initiated2016-05-02
Date Terminated2017-04-10
Product Quantity81 units

Reason for Recall

One of the dent markers from the DX-D600 dropped down from the overhead rail.

Firm Action

On May 2, 2016, an "URGENT FIELD SAFETY NOTICE" letter was either emailed or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment to be sent back. The letter described background information and actions to be taken.

Root Cause

Labeling design

Distribution Pattern

AL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112670DX-D 600Agfa Healthcare N.V. · 2011-10-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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