CLASS II ONGOING Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
Carescape Central Station (Cscs) V2.0x MAI700 (Integrated) recalled
GE Healthcare is recalling Carescape Central Station (Cscs) V2.0x MAI700 (Integrated), distributed nationwide in the US. The recall was initiated on 28 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0808-2022
- FDA event ID
- 89576
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Jan 2022
- FDA classified
- 16 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Jan 2022 | Recall initiated by company | |
| 16 Mar 2022 | Classified by FDA | +47 days |
| 23 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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