Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
FDA Recall Z-0535-05 · Posted 2005-02-10
Advertisement
Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeDPS
Date Initiated2005-01-05
Date Terminated2005-11-14
Product Quantity4
Reason for Recall
An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading.
Firm Action
On 12/22/04 distribution of new units was placed on hold and customers were notified to recommend that they do not use the pace detect function. On 12/27/03 an email was sent to customers of the solution. On 12/29/04 a Technical Worksheet describing how to replace a resistor at R8 was emailed to customers. Between 12/29/04 and 01/03/05 kits containing instructions and new resistors were sent to customers to begin reworking of the devices.
Root Cause
Other
Distribution Pattern
Internationally only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement