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Terminated

Sienet MagicStore. Radiological Digital Image Communications System

FDA Recall Z-0890-2007 · Posted 2007-06-05

Recall StatusTerminated
Product CodeLMD
Date Initiated2007-05-02
Date Terminated2008-09-17
Product Quantity19 units

Reason for Recall

System could crash and result in data loss.

Firm Action

The recalling firm issued a Safety Advisory letter to their customers (May 2, 2007) to inform them of the problem. A company representative will be contacting the customers to arrange for replacement of the RAID component.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in CA, CO, FL, MS, NH, NJ, NY, and WA.

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.

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