GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiolog
FDA device recall Z-0806-2014 · posted 2014-01-22 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated December 5, 2013, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044. For questions regarding this recall call 262-513-4122.
- Root cause
- Pending
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 47,125 (38,710 US, 8,415 OUS)
- Distribution
- Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA,
- Date initiated
- 2013-12-05
- Date posted
- 2014-01-22
- Date terminated
- 2016-07-25
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES (K073462) | Ge Medical Systems Information Technologies | 2008-01-11 |