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Terminated

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

FDA Recall Z-0481-2016 · Posted 2015-12-24

Recall StatusTerminated
Product CodeOWB
Date Initiated2015-10-30
Date Terminated2017-03-28
Product Quantity17

Reason for Recall

Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.

Firm Action

Siemens sent an Important Customer Safety Notice dated October 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The issue will be remedied with a hardware update AX025/15/S. The affected bypass module hardware will be exchanged with unaffected production lots to eliminate the problem. For further questions call: (610) 219-6300.

Root Cause

Software design

Distribution Pattern

US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.

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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