FDA-Device2014-02-12Class II

IMPAX RIS QDOC 5.8

AGFA Corp.
Hazard

Patient name displayed (printed) on the Patient Report was the wrong patient name.

Sold states
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Affected count
14
Manufactured in
10 S Academy St, Greenville, SC, United States
Products
IMPAX RIS QDOC 5.8

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2014

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