The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninva
FDA device recall Z-0633-2014 · posted 2014-01-07 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
- Action taken
- Welch Allyn began sending out the Urgent Medical Device Correction letter, dated December 03, 2013, to consignees on December 10, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customer Actions: In the unlikely event that operation of your Propaq LT is interrupted and the display becomes blank or white, pressing the power (on/off) button will restart the device and quickly bring it back to full operational capacity. This notice should be passed on to all those who need to be aware within your organization, or to any organization where the potentially affected devices have been transferred. Welch Allyn is in the process of developing a software installation service tool that will enable installation of the software update by your biomed, IT staff or other technically qualified personnel. Upon release, the service tool will be made available to you via a download from Welch Allyn's website at www.welchallyn.com/PropaqltUpgrade or other media. In the meantime and on an on-going basis, the software update will be included if you schedule routine or other service with Welch Allyn or an authorized service provider. Customers with questions were instructed to call Welch Allyn Technical Support at 1-800-535-6663. For questions regarding this recall call 503-530-7935.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 6003 units total (1715 units in the US and 4288 outside the US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, G
- Date initiated
- 2013-11-21
- Date posted
- 2014-01-07
- Date terminated
- 2015-02-17
- Location
- Beaverton, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITAL SIGNS MONITOR, PROPAQ LT (K033378) | Welch Allyn Protocol, Inc. | 2004-03-01 |