Recall Z-0633-2014 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Welch Allyn Protocol, Inc
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and ot
| Date | Jan 7, 2014 (initiated Nov 21, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 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, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT Welch Allyn Protocol, Inc., Mar 1, 2004 |