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Terminated

Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020

FDA Recall Z-1272-02 · Posted 2004-07-20

Recalling FirmDen-Tal-Ez Inc,Star Dental Div
Recall StatusTerminated
Date Initiated2003-05-16
Date Terminated2004-03-19
Product Quantity231 units

Reason for Recall

problems with product label

Firm Action

The recalling firm issued recall letters to the accounts via certified mail on 5/16/03.

Root Cause

Other

Distribution Pattern

The products were shipped to 6 accounts in PA, IL, UT, MD, and NY. Three accounts are government/military locations.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021378PORTABLE HDX INTRAORAL X-RAYDentalez Group · 2002-06-07

Official Source

View FDA Recall →

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

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