GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Device Recall #Z-2085-2014 — Class II — June 13, 2014
Recall Summary
| Recall Number | Z-2085-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 13, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 41,992 (20,509 US; 21,483 OUS) |
Product Description
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Reason for Recall
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
Distribution Pattern
Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.
Lot / Code Information
CARESCAPE MONITOR B850: Mfg Lot or Serial # System ID PA1793340 2044032-002+940481 PA1841631 2044032-002+956091 PA1841635 2044032-002+956091 PA1841639 2044032-002+956091 PA1962678 2044032-002+950202 SED09130286GP 2042395-001+889146 SED09130290GP 2042395-001+889146 SED09130291GP 2042395-001+889146 SED09130296GP 2042395-001-884783 SED09130298GP 2042395-001+889146 SED09130302GP 2042395-001+889148 SED09130304GP 2042395-001+887796 SED09130307GP 2042395-001-885430 SED09130312GP 2042395-001+889880 SED09180333GP 2042395-001+889148 SED09180334GP 2042395-001+887796 SED09180338GP 2042395-001+889148 SED09180341GP 2042395-001+889880 SED09220344GP 2042395-001+889880 SED09220345GP 2042395-001+889880 SED09220346GP 2042395-001+889880 SED09220347GP 2042395-001+889880 SED09220348GP 2042395-001+889880 SED09220350GP 2042395-001+889880 SED09220355GP 2042395-001+889880 SED09220357GP 2042395-001+889880 SED09220358GP 2042395-001+889880 SED09220365GP 2042395-001+889880 SED09220367GP 2042395-001+889880 SED09220371GP 2042395-001+889880 SED09220372GP 2042395-001+889880 SED09220373GP 2042395-001+889880 SED09220375GP 2042395-001+889880 SED09220377GP 2042395-001+889880 SED09220378GP 2042395-001+889880 SED09220380GP 2042395-001+889880 SED09220381GP 2042395-001+889880 SED09220382GP 2042395-001+889880 SED09220383GP 2042395-001+889880 SED09230384GP 2042395-001+889880 SED09230385GP 2042395-001+889880 SED09230386GP 2042395-001+889880 SED09230388GP 2042395-001+889880 SED09230390GP 2042395-001+889880 SED09240401GP 2042395-001+889880 SED09280402GA 2042395-001+889072 SED09280403GA 2042395-001+889072 SED09280404GA 2042395-001+905096 SED09280405GA 2042395-001+893818 SED09280406GA 2042395-001+889074 SED09280407GA 2042395-001+895722 SED09280409GA 2042395-001+895148 SED09280412GA 2042395-001+895722 SED09280415GA 2042395-001+895726 SED09280417GA 2042395-001+895726 SED09280418GA 2042395-001+895148 SED09280421GA 2042395-001+895722 SED09280424GA 2042395-001+889074 SED09280425GA 2042395-001+895148 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Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.