GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Pro
FDA device recall Z-0802-2015 · posted 2014-12-19 · Terminated
Recall details
- Recalling firm
- Leonhard Lang Gmbh
- Reason for recall
- The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.
- Action taken
- The one consignee was sent an Urgent Medical Device Recall letter, dated 12/3/2014. The letter identified affected product, explained the issue, and asked for product to stop being used and distributed, and to return the devices. Questions can be addressed to Bettina Sarlay, Sales Manager, Leonhard Lang, at bettina.sarlay@leonhardlang.at.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 1080 pieces
- Distribution
- US Nationwide Distribution in the states of OH and TX.
- Date initiated
- 2014-12-03
- Date posted
- 2014-12-19
- Date terminated
- 2015-08-13
- Location
- Innsbruck, Austria
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (K081371) | Leonhard Lang GmbH | 2008-09-24 |