Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor. |
| Product | GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. |
| Quantity | 21,799 (7,635 units US, 14,164 units OUS) |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, ZAMBIA, YEMEN, VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, UNITED REPUBLIC OF TANZANIA, TAJIKISTAN, TAIWAN, SYRIA, SWITZERLAND, SWEDEN, SRILANKA, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FDRATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PARAGUAY, P… |
| Initiated | 2014-07-07 |
| Classified | 2014-07-24 |
| Terminated | 2016-09-07 |
| Recall number | Z-2114-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-2114-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68378/
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