Z-1326-2009

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

Name: Z-1326-2009 Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225...
Creator: Smiths Medical PM, Inc.
Published: 2008-12-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-12-22 / Terminated / root cause: design

FDA source

Smiths Medical PM, Inc. began a recall of Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325... on 2008-12-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1326-2009
Status: Terminated
Initiated: 2008-12-22
Posted: 2009-05-15
Terminated: 2011-12-17
Recalling firm: Abbott Medical
Product: 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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Product code CCK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)