Recall Z-1389-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Welch Allyn Protocol, Inc
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
| Date | Jun 23, 2009 (initiated Feb 26, 2009) |
| Status | Terminated |
| Reason | Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts. |
| Root cause | Component design/selection |
| Action | Welch Allyn sent an Urgent Medical Device Recall letter dated February 26, 2009 to all distributors and customers, describing 5 failure modes. Customers were instructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new purchase. |
| Quantity | Issue #1: 4568 units; Issue#2: 5186 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021168 | JUMP START, MODEL 970300 Medical Research Laboratories, Inc., Jun 26, 2002 |