GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervi
FDA device recall Z-0494-2013 · posted 2012-12-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors.
- Action taken
- GE Healthcare sent a Important Product Information Letter dated June 21, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If your facility is using the Custom Auto NBP Measurement feature in conjunction with Automatic View On Alarm and/or View Other Beds options, GE Healthcare recommends that you stop using the Custom Automatic NBP Measurement feature and use the Auto NBP function instead. All Dash3000/4000/5000 patient monitors with software version 6.0 and later with the networking option enabled may be affected. You can determine the software version of the Dash monitors by selecting MORE MENUS > MONITOR SETUP > SOFTWARE CONFIGURATION. Product Correction GE Healthcare is working on a software correction that will be provided to you at no charge once it is available. We will contact you to schedule the correction. Contact Information If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above. .
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 119,260 devices
- Distribution
- Worldwide Distribution -- USA (nationwide) including the countries of AUSTRALIA, ANGOLA,ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODI
- Date initiated
- 2012-06-26
- Date posted
- 2012-12-16
- Date terminated
- 2017-06-23
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |