GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to colle
FDA device recall Z-0487-2018 · posted 2018-01-25 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Technologies, Inc.
- Reason for recall
- CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
- Action taken
- The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and email to its consignees on 01/11/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions and follow the safety instructions. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044 or your local Service Representative.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 1803 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Algeria, Australia, Austria, Canada, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia,
- Date initiated
- 2018-01-11
- Date posted
- 2018-01-25
- Date terminated
- 2021-07-07
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE Central Station V2 (K162012) | GE Healthcare | 2016-09-15 |