Recall Z-0808-2022 ยท DXJ Display, Cathode-Ray Tube, Medical
GE Healthcare, LLC
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
| Date | Mar 16, 2022 (initiated Jan 28, 2022) |
| Status | Open, Classified |
| Reason | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. |
| Root cause | Software design |
| Action | The recalling firm began issuing the notification letters on 1/28/2022 via FedEx in the U.S. to the following titles within the affected accounts: Director of Biomedical/Clinical Engineering, Chief of Nursing, Health Care Administrator/Risk Manager. The letter contained a black box at the top saying the document contains important information for the product and to ensure all potential users in the facility are made aware of this safety notification and recommended actions. The letter informed the recipient of the safety issues and the actions to be taken. The actions included that it was |
| Quantity | 10,445 units |
| Distribution | Worldwide distribution - US nationwide, including Puerto Rico. There was also government/military distribution. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cote d'lvoire, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162012 | CARESCAPE Central Station V2 GE Healthcare, Sep 15, 2016 |