GE Healthcare CARESCAPE Central Station recall
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
Why was GE Healthcare CARESCAPE Central Station 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
- Recalling firm
- GE Healthcare, LLC
- 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, 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.
- Recall date
- March 23, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)