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 clinic where low-end monitoring systems are needed.
This recall has been terminated (originally issued May 15, 2009).
- Company
- Smiths Medical Pm, Inc. N7
- Recall Initiated
- December 22, 2008
- Posted
- May 15, 2009
- Terminated
- December 17, 2011
- Recall Number
- Z-1326-2009
- Quantity
- 143 monitors (17 US, 126 OUS)
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
serial numbers: AM08070014, AM08070015, AM08080004, AM08080005, AM08080006, AM08080007, AM08080008, AM08080009, AM08080010, AM08080011, AM08080012, AM08080013, AM08080014, AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08080032, AM08080033, AM08080034, AM08080035, AM08080036, AM08080037, AM08080038, AM08080039, AM08080040, AM08080041, AM08080042, AM08080043, AM08080044, AM08080045, AM08080046, AM08080047, AM08080048, AM08080049, AM08080050, AM08080051, AM08080052, AM08080075, AM08080076, AM08080077, AM08080078, AM08080079, AM08090058, AM08090059, AM08090060, AM08090061, AM08090069, AM08090070, AM08090071, AM08090072, AM08090073, AM08090074, AM08090075, AM08090076, AM08090077, AM08090078, AM08090079, AM08090080, AM08090081, AM08090082, AM08090083, AM08090084, AM08090085, AM08090086, AM08090092, AM08090093, AM08090094, AM08090095, AM08090096, AM08090097, AM08100000, AM08100001, AM08100002, AM08100003, AM08100004, AM08100005, AM08100006, AM08100007, AM08100008, AM08100042, AM08100043, AM08100045, AM08100051, AM08100052, AM08100053, AM08100054, AM08100056, AM08100075, AM08100076, AM08100077, AM08100078, AM08100080, AM08100082, AM08100083, AM08100085, AM08100086, AM08100087, AM08100088, AM08100089, AM08100091, AM08100092, AM08100093, AM08100094, AM08100095, AM08100096, AM08100097, AM08100098, AM08100099, AM08100100, AM08100101, AM08100146, AM08110000, AM08110001, AM08110003, AM08110004, AM08110005, AM08110008, AM08110009, AM08110010, AM08110011, AM08110012, AM08110013, AM08110014, AM08110015, AM08110016, AM08110018, AM08110019, AM08110026, AM08110027, AM08110028, AM08110029, AM08110030, AM08110031, AM08110034, AM08110035, AM08110036, AM08110037, AM08110054, AM08110055, AM08110056, and AM08110058.
Root Cause
Device Design
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.