Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
FDA device recall Z-0538-04 · posted 2004-02-13 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Potential failure to audibly alarm due to speaker hardware component failure.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 233 devices
- Distribution
- The firm distributes the product nationwide and internationally.
- Date initiated
- 2003-12-31
- Date posted
- 2004-02-13
- Date terminated
- 2005-01-06
- Location
- Beaverton, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM (K022453) | Welch Allyn Protocol, Inc. | 2002-08-21 |