Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 9254

FDA device recall Z-1326-2009 · posted 2009-05-15 · Terminated

Recall details

Recalling firm

Smiths Medical PM, Inc.

Reason for recall

Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. There have been no adverse events or injuries reported.

Action taken

An Urgent Product Safety Information, Voluntary Recall Notification, dated 12/22/08, was sent to affected consignees. The notification contained a Safety Action Bulletin which provided actions to be taken. The Safety Action Bulletin described the issue, requested customer to contact Smiths Medical to ensure proper mounting hardware is utilized for those consignees using a roll stand or wall mount. If the consignee further distributed the product, they were asked to forward on the Safety Action Bulletin to the end user. Page 3 of the Safety Action Bulletin was asked to be completed and returned to Smiths Medical PM, Inc. A second "Urgent Product safety Information Voluntary Recall Notification" letter dated January 16, 2009 was sent to consignees. The second letter included a risk statement associated with the recalled product.

Root cause

Device Design

Status

Terminated

Product code

CCK

Quantity affected

143 monitors (17 US, 126 OUS)

Distribution

Worldwide Distribution -- USA including states of FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador, Greece, Peru, Romania, Russia, Singapore, Slovenia, Trinidad and Tobago, United Ki

Date initiated

2008-12-22

Date posted

2009-05-15

Date terminated

2011-12-17

Location

Waukesha, WI

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