Recall Z-0538-04 ยท DSI Detector And Alarm, Arrhythmia
Welch Allyn Protocol, Inc
Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
| Date | Feb 13, 2004 (initiated Dec 31, 2003) |
| Status | Terminated |
| Reason | Potential failure to audibly alarm due to speaker hardware component failure. |
| Root cause | Other |
| Action | The firm sent a letter dated December 31, 2003 instructing their customers to install an audio cable from the CPU to the Flat Panel Monitor to provide redundant speaker capability. The audio cable and installation instructions were included in the letter. The letter also included a Correction Response Form which customers should fill out upon completion of correction. |
| Quantity | 233 devices |
| Distribution | The firm distributes the product nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022453 | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM Welch Allyn Protocol, Inc., Aug 21, 2002 |