Recall Z-0531-05 ยท DPS Electrocardiograph
Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. 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 a
| Date | Feb 10, 2005 (initiated Jan 5, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 11 |
| Distribution | Internationally only. |
| FDA record | Open on fda.gov |