Recall Z-1649-2008 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Smiths Medical PM, Inc.
BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,
| Date | Aug 25, 2008 (initiated Apr 2, 2008) |
| Status | Terminated |
| Reason | Due to a component that may be installed backwards, the device may turn off or may immediately reset. |
| Root cause | Employee error |
| Action | Consignees were contacted on 4/2/08 with a Safety Action Bulletin, 08-SAB02, and Technical Worksheet 08-TW01 dated April 1, 2008, which included information regarding the potential safety issue and the proper inspection method for the monitor(s). If you have not received the Safety Action Bulletin or the Technical Worksheet contact Smiths Medical PM, Inc. at Telephone: (262) 542-3100 or Toll Free: (USA): (800) 558-2345 or email info.pm@smiths-medical.com. |
| Quantity | 195 |
| Distribution | USA: IL, FL, TX, IA, CA, ID, MD, AZ, MN, PA, CO, IN, KS, WA, TN, AL, WI, NM, LA, and PR. OUSA: Argentina, Canada, Ecuador, Greece, Hong Kong, Italy, Pakistan, Peru, Russia, saudi Arabia, Slovakia, Thailand, United Kingdom |
| FDA record | Open on fda.gov |