Z-0808-2022Class II

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700...

Name: Z-0808-2022 GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700...
Creator: GE Healthcare, LLC
Published: 2022-01-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-01-28 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001 on 2022-01-28. FDA classified it as Class II and gives the reason as "If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0808-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-28
Posted: 2022-03-16
Recalling firm: GE Healthcare
Product: GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
Product code: DXJ Display, Cathode-Ray Tube, Medical
Reason for recall: 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 tag: software
FDA 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 important to ensure the staff continues to be aware of the serious risks if an unapproved keyboard is used with the CSCS v2.0. They are to ensure all users who interact with CSCS v2.0 are fully aware of, understand, and always follow the instructions provided in the letter. The instructions included that the CARESCAPE Central Station v2.0 with the GE-approved keyboard that is shipped with every CARESCAPE Central Station can continue to be used. Characteristics of the approved GE keyboard were provided for identification. If the recipient is not using a GE-approved keyboard with the CSCS v2.0, they are to follow instructions which include: (1) Ensure it is not muted and steps are provided to confirm it is not muted; (2) Replace any unapproved keyboard with a GE-approved keyboard; (3) If the unapproved keyboard cannot be replaced immediately, (a) Ensure the mute key is not pressed as it will silence all audible alarms; and b) Post these instructions at each CSCS v2.0. The instructions are also listed in Appendix A at the end of the letter. In addition, Appendix B at the end of the letter shows the part numbers for the GE-approved keyboards that can be used with the CARESCAPE Central Station V2.0. Affected Product Details are provided which lists the encompassed software versions, the Model Identifier, and where to find the three-letter Product Code identifier that is found
Quantity in commerce: 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, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Ghana, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, Nigeria, Norway, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Product codes and lots: Version 2.0.x (v2.0.0, v2.0.1, v2.0.2, or v2.0.3) with serial numbers beginning with SKN for the MAI700 Integrated, UDI 00840682109666 and serial numbers beginning with SNF for the MAI700 Integrated, UDI 0100840682109604; or serial numbers beginning with SNF for the MAS700 Desktop, UDI 00840682109604.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0808-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0808-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-16

Product code DXJ

K162012Class IICARESCAPE Central Station V2GE Healthcare / cleared 2016-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)