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Terminated

Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

FDA Recall Z-2176-2014 · Posted 2014-08-10

Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeIZL
Date Initiated2014-05-13
Date Terminated2014-08-13
Product Quantity1

Reason for Recall

Unit was mislabeled with a factory label showing 32 KW output power.

Firm Action

Only one customer was affected no customer letter was issued field correction was conducted..

Root Cause

Labeling mix-ups

Distribution Pattern

US in the state of WV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103597DX-D 100Agfa Healthcare N.V. · 2011-01-03

Official Source

View FDA Recall →

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

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