Propaq LT vital signs monitor, Model 802LTON
FDA device recall Z-0215-2007 · posted 2006-11-28 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.
- Action taken
- A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- total of both models 1031
- Distribution
- Devices were distributed to hospitals/medical centers and dealers worldwide.
- Date initiated
- 2006-10-22
- Date posted
- 2006-11-28
- Date terminated
- 2011-08-02
- Location
- Beaverton, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITAL SIGNS MONITOR, PROPAQ LT (K033378) | Welch Allyn Protocol, Inc. | 2004-03-01 |