Recall Z-1326-2009 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Smiths Medical PM, Inc.
Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clini
| Date | May 15, 2009 (initiated Dec 22, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 ret |
| Quantity | 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 Kingdom, and Uruguay. |
| FDA record | Open on fda.gov |