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Terminated

Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969

FDA Recall Z-0069-2007 · Posted 2006-10-25

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-10-03
Date Terminated2008-04-23
Product Quantity5 units

Reason for Recall

Potential loss of images. Images may not successfully be sent to the RAID system.

Firm Action

The recalling firm has issued a software patch to resolve the issue via Update Instructions HS110/06/S. The Update Instructions direct a Siemens Service Representative to visit the affected sites, install the software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20th, 2006, to the customer to notify them of the issue.

Root Cause

Other

Distribution Pattern

The product was shipped to hospitals in CA, MD, MO, and PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042832SIENET COSMOS (VERSION V15A)Siemens AG Medical Solutions · 2004-10-28

Official Source

View FDA Recall →

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

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