Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Sta
FDA device recall Z-0701-2016 · posted 2016-01-29 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained.
- Action taken
- The firm, Mindray DS USA, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 12/15/2015 to its customers via certified mail. The letter described the product, problem, and actions to be taken. The customers were instructed to route the recall letter to all potential users of your facility. Mindray will resolve the issue by upgrading the system software on all affected Panorama systems in your facility. Please contact your Mindray Service Representative at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm) to arrange upgrade. If you have any questions, please contact Director, Quality Operations and Regulatory Affair at 201-995-8407 or email to: d.arpino@mindray.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 63 products
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-12-15
- Date posted
- 2016-01-29
- Date terminated
- 2017-03-29
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Panorama Patient Monitoring Network (K150082) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-09-02 |