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Terminated

BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)

FDA Recall Z-1089-2007 · Posted 2007-07-23

Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeMWI
Date Initiated2007-06-05
Date Terminated2008-10-29
Product Quantity57

Reason for Recall

Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.

Firm Action

Consignees will be contacted via a Safety Action Bulletin 07-SAB02 dated June 5, 2007. Technical Worksheet, 07-TW01 including a kit will be sent to the International consignees whom Technical Service has deemed qualified to perform the repair. The repair will be performed at the consignee site. International consignees who require or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return their monitors for repair.

Root Cause

Other

Distribution Pattern

International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030407ADVISOR, MODEL 9200Bci, Inc. · 2003-08-19K010770BCI ADVISOR VITAL SIGNS MONITOR (9200)Bci, Inc. · 2001-06-12K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200Bci Intl., Inc. · 1998-09-25

Official Source

View FDA Recall →

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

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