GE Healthcare — Class II medical device recall Z-2114-2014

Terminated recall by GE Healthcare, LLC, reported 2014-07-30, distributed nationwide. Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the C

Recall number	`Z-2114-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	GE Healthcare, LLC, Waukesha, WI, United States
Recall initiated	2014-07-07
Classified	2014-07-24
Reported by FDA	2014-07-30
Terminated	2016-09-07
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BD, BE, BG, BH, BM, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JM, JO, JP, KR, KW, LB, LT, LV, MA, MX, MY, NI, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, SV, TH, TR, TW, UY, VE, VN, ZA

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.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2114-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.