GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
FDA device recall Z-0982-2014 · posted 2014-02-14 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network. 4.
- Action taken
- Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated November 27,2013. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative).
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 178,711 (92,123 US, 86,588 OUS)
- Distribution
- Worldwide Distribution: USA (nationwide) including DC and PR; and Internationally to: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HE
- Date initiated
- 2013-11-27
- Date posted
- 2014-02-14
- Date terminated
- 2016-08-25
- Location
- Waukesha, WI
Monitor recalls programmatically
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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 |
| DASH 3000 PATIENT MONITOR (K992929) | General Electric Medical Systems Information Techn | 1999-11-26 |