Events

Recall of Device Recall GE Healthcare, CARESCAPE Monitor B850

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66156
  • Event Risk Class
    Class 2
  • Event Number
    Z-2201-2013
  • Event Initiated Date
    2011-07-20
  • Event Date Posted
    2013-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121583
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Ge healthcare has recently become aware of an issue associated with the carescape monitor b850 when used with the icentral network. the icentral must have the alarm management software license (l-netm-00) and the alarm limit change option enabled to experience this issue. when changing the hr, spo2 or invasive pressure alarm limits from the icentral over the network, the alarm priority on th.
  • Action
    Consignees were sent on 7/20/2011 a GE Healthcare "Important Product Information" letter. The letter was addressed to Healthcare Administrator / Risk Manager, chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Instructions, Product Correction, and Contact Information (Technical Support 1-800-558-7044).

Device

Device Recall GE Healthcare, CARESCAPE Monitor B850
  • Model / Serial
    Serial Number 6617967 6617968 6617969 6619157 6619158 6619159 6619160 6626633 6626634 6637287 6660104 6693980 6720596 6720597 6720598 6720599 6739266 CZC0044VY8 CZC0044VYL CZC0044VYY CZC0044VZ1 CZC0044VZ5 CZC0044VZ6 CZC0044VZ7 CZC0044VZ8 CZC0044VZB CZC0070P7B CZC0070P7G CZC0133FMM CZC0133FMS CZC0133FN7 CZC0182JL2 CZC0182JL8 CZC02211YN CZC0249CL3 CZC0249CL5 CZC0249CL7 CZC0249CLF CZC0249CLK CZC03336CT CZC03336D1 CZC03336D6 CZC0334KJ5 CZC0334KJ6 CZC0366ZR0 CZC0468W4H CZC1027W82 CZC1027W85 CZC1027W86 CZC1027W8C CZC1129Z65 CZC116B2N7 CZC9313455 CZC0016T0H CZC0016T0T CZC0044VY7 CZC0044VY9 CZC0044VYD CZC0044VYM CZC0044VYP CZC0044VYQ CZC0044VYR CZC0044VYV CZC0044VZ2 CZC0044VZ9 CZC0044VZC CZC0133FMJ CZC0207NVR CZC0207NVS CZC02211YD CZC02211YG CZC02211YT CZC0249CLJ CZC0322T5K CZC0334KJM CZC0369HKQ CZC1069WFK CZC1069WFT CZC1129Z6D CZC1129Z6Y CZC1129Z73 CZC94890S5 CZC94890S7 CZC94890SD CZC0322T5G CZC0322T5J CZC0070P7S CZC0133FN4 CZC02213JC CZC02213JF CZC02213JG CZC02213JJ CZC0526KZ1 CZC1069WF7 CZC1069WF9 CZC1129Z63 CZC1129Z6B CZC1129Z6C CZC1129Z74 CZC94890S1 CZC94890S8 CZC94890SC CZC94890SK CZC0070P82 CZC03336C8 CZC0107DR3 CZC0070P7X CZC0107DQ7 CZC0182JL7 CZC0182JLF CZC0207NVP CZC0334KJF CZC0474PTP CZC0474PVK CZC1027W8M CZC1069WF5 CZC1069WFB CZC1129Z68 CZC1129Z6R CZC1129Z6Z CZC0107DQ3 CZC0107DQR CZC0334KJJ CZC1027W7W CZC1069WF1 CZC1129Z64 CZC0107DQ6 CZC0107DQ8 CZC0334KJH CZC0334KJR CZC0474PTK CZC0526KZ6 CZC0526KZ8 CZC0107DQ9 CZC0107DR4 CZC02213J9 CZC02213JL CZC03336CJ CZC0468W53 CZC1129Z6J CZC1129Z6T CZC0107DQ1 CZC0107DQB CZC0107DQC CZC0107DQZ CZC03336CN CZC0366ZQT CZC0369HL1 CZC0474PV0 CZC0526KYN CZC1069WF3 CZC1129Z76 CZC0133FNB CZC02211YF CZC02211YH CZC0369HL2 CZC0232J70 CZC0182JL4 CZC0133FMY CZC0133FN0 CZC0133FN2 CZC02211YB CZC02211YQ CZC0249CLC CZC03336CM CZC0334KJC CZC0369HLL CZC0468W46 CZC0468W4Q CZC0468W4R CZC1027W8B CZC1027W8N CZC0249CLL CZC0044VYK CZC0474PTY CZC0044VZ4 CZC0070P78 CZC0070P7L CZC0070P7Q CZC0070P7T CZC0070P7V CZC0070P80 CZC0107DQK CZC0107DR1 CZC0207NW0 CZC0207NW3 CZC0207NVX CZC0207NVY CZC0249CL1 CZC0249CLG CZC0468W41 CZC0468W4K CZC0468W4S CZC0468W4X CZC0468W52 CZC0474PTR CZC0474PV2 CZC0526KYK CZC0526KYR CZC0526KZ2 CZC1027W8F CZC1069WDY CZC0070P7F CZC0016T05 CZC0016T07 CZC02213J5 CZC02213J7 CZC02213J8 CZC02213JK CZC0334KJN CZC0366ZQN CZC0366ZQP CZC0366ZQV CZC0366ZQW CZC0366ZQZ CZC0366ZR4 CZC0366ZRC CZC0366ZRQ CZC0366ZRS CZC0369HKJ CZC0369HKR CZC0369HKT CZC0369HKV CZC0369HKZ CZC0369HLC CZC0369HLM CZC1069WG2 CZC116B2NQ CZC0366ZRK CZC0366ZRM CZC0468W50 CZC0468W51 CZC0526KZM CZC0322T5C CZC0366ZRF CZC0366ZRH CZC0474PVH CZC0474PVL CZC0526KZ9 CZC1027W7Z CZC1129Z69 CZC1129Z6K CZC1129Z6P CZC0369HLF CZC0070P7Y CZC0070P84 CZC0107DQ0 CZC0249CL9 CZC0366ZQR CZC0526KZ4 CZC0526KZH CZC0526KZP CZC1027W7K CZC1027W7S CZC1027W83 CZC1027W8P CZC1069WF0 CZC0107DQ2 CZC0107DQM CZC0207NW1 CZC0207NVN CZC02211YS CZC0322T5H CZC0322T5L CZC03336CS CZC03336D7 CZC0334KHT CZC0366ZRP CZC0369HKP CZC0369HKW CZC0369HL7 CZC0369HLJ CZC0468W4V CZC0468W4W CZC0468W54 CZC0526KYQ CZC0526KZN CZC1069WDZ CZC1069WF6 CZC1069WFF CZC1069WFG CZC1069WFP CZC1069WFQ CZC1129Z66 CZC1129Z6M CZC1129Z6X CZC116B2NK CZC0070P77 CZC0070P7J CZC0133FN6 CZC116B2N9 CZC02211YC CZC03336CZ CZC0468W4Y CZC0474PTN CZC03336CK CZC03336CK CZC0369HL4 CZC1129Z6F CZC1129Z6Q CZC0366ZQQ CZC0366ZQX CZC0366ZQY CZC0366ZR1 CZC0016T09 CZC0070P73 CZC0070P74 CZC0070P7D CZC0133FN9 CZC0133FND CZC0133FNH CZC02213J2 CZC02213J6 CZC02213JH CZC0249CL4 CZC0249CLD CZC0322T55 CZC03336CF CZC03336CR CZC03336D0 CZC0468W4J CZC0468W4M CZC0526KYV CZC0526KZ0 CZC0526KZB CZC0526KZC CZC0526KZL CZC1027W7T CZC1069WFC CZC1069WFV CZC1129Z6L CZC116B2NC CZC9451GNQ CZC03336D3 CZC03336D5 CZC0334KJD CZC0526KYX 6679180 6682211 6693988 6726016 6726017 CZC0016T08 CZC0044VYH CZC0070P7C CZC0070P85 CZC0070P86 CZC0107DQJ CZC0107DQT CZC0107DR2 CZC0133FMK CZC0133FMQ CZC0133FMW CZC0133FMW CZC0133FMX CZC0182JL6 CZC02211YV CZC02213J3 CZC0249CL8 CZC0322T57 CZC0322T5B CZC0322T5N CZC03336C7 CZC03336CG CZC03336D8 CZC0334KHR CZC0334KHX CZC0334KHY CZC0334KJ0 CZC0334KJ8 CZC0334KJG CZC0366ZQS CZC0366ZR5 CZC0366ZRB CZC0366ZRD CZC0366ZRG CZC0369HKK CZC0369HL0 CZC0369HL3 CZC0369HLD CZC0369HLK CZC0468W49 CZC0468W4C CZC0468W4L CZC0468W55 CZC0474PTW CZC0474PV4 CZC0474PV6 CZC0474PV8 CZC0474PV9 CZC0474PVM CZC0474PVN CZC0474PVP CZC0526KYY CZC0526KYZ CZC0526KZ3 CZC0526KZJ CZC1027W7L CZC1027W7Q CZC1027W7R CZC1027W7X CZC1027W81 CZC1027W84 CZC1027W8L CZC1069WF4 CZC1069WF8 CZC1069WFD CZC1069WFR CZC1069WFS CZC1069WFY CZC1129Z6V CZC1129Z6W CZC1129Z72 CZC116B2NB CZC116B2ND CZC116B2NF CZC116B2NG CZC116B2NH CZC116B2NR 6585808 6585809 6585810 6585811 6585812 6637282 6660108 6660109 6660110 6660111 6693989 6726013 CZC0016SZR CZC0016SZY CZC0016T00 CZC0107DQH CZC0107DQV CZC0133FNG CZC0182JKZ CZC0182JLC CZC0182JLG CZC0182JLH CZC0182JLO CZC0207NW2 CZC0207NW4 CZC0232J6Z CZC0232J73 CZC0249CL2 CZC0322T54 CZC0322T59 CZC0322T5D CZC0322T5F CZC0322T5M CZC0322T5P CZC03336C9 CZC03336CX CZC03336CY CZC0334KJ9 CZC0366ZRL CZC0369HKX CZC0369HKY CZC0369HL5 CZC0369HL6 CZC0369HL9 CZC0369HLG CZC0369HLH CZC0468W42 CZC0468W45 CZC0468W48 CZC0468W4B CZC0468W4F CZC0468W4G CZC0468W4T CZC0468W4Z CZC0474PTM CZC0474PTX CZC0474PTZ CZC0474PV3 CZC0474PV7 CZC0474PVB CZC0474PVC CZC0474PVD CZC0474PVF CZC0474PVJ CZC0526KZF CZC0526KZG CZC0526KZK CZC1027W7V CZC1069WFW CZC1069WG0 CZC1069WG1 CZC1129Z6G CZC1129Z75 6654942 6654944 CZC0107DQN CZC0107DQY CZC0133FNK CZC0207NVW CZC0207NVZ CZC02211YM CZC03336CB CZC03336CV CZC0334KJT CZC0369HKM CZC0369HL8 CZC0474PV1 CZC0526KYM CZC1129Z6N 6706167 CZC0070P7H CZC0207NVT CZC0207NVV CZC03336CL CZC0182JL9 6585804 6614833 CZC0044VYW CZC0044VYZ CZC0044VZ3 CZC0070P7R CZC0070P81 CZC1027W8D CZC1027W8K CZC02211Y9 CZC0526KYL CZC1027W8J CZC03336D2 CZC0107DQ5 CZC0474PTQ CZC0207NW5 CZC0207NVQ CZC0044VYB CZC0249CLH CZC0369HKN CZC0474PTT CZC0044VYN CZC0044VZ0 CZC0322T56 CZC0334KJW CZC0474PTV CZC0526KYW CZC0526KZD CZC1027W88 CZC1027W8H CZC0232J74 CZC0107DQ4 CZC0107DQD CZC0107DQG CZC0107DQL CZC0107DQP CZC0107DQQ CZC0107DQW CZC0107DR0 CZC0133FMN CZC02211YK CZC0474PTL CZC0474PTS CZC0474PV5 CZC0526KYS CZC0526KZ7 CZC1069WFH CZC116B2NM CZC03336D9 CZC03336DC 6619123 6619124 6679163 CZC0044VYS CZC0070P7K CZC0070P7P CZC0070P83 CZC0133FN1 CZC0133FN3 CZC0133FNC CZC0133FNF CZC0182JL3 CZC02211YJ CZC02211YL CZC02211YP CZC02211YR CZC0249CL6 CZC0249CLB CZC03336CC CZC03336CD CZC03336CH CZC03336CP CZC03336CQ CZC03336CW CZC03336D4 CZC03336DB CZC0334KJS CZC0334KJV CZC0366ZR3 CZC0366ZR6 CZC0366ZR9 CZC0366ZRN CZC0366ZRR CZC0369HKL CZC0369HKS CZC0468W44 CZC0468W47 CZC0468W4D CZC0468W4N CZC0468W4P CZC0474PVG CZC0526KYP CZC1069WF2 CZC1069WFJ CZC1069WFL CZC1069WFX CZC1069WFZ CZC1129Z62 CZC1129Z67 CZC1129Z6H CZC1129Z6S CZC1129Z70 CZC1129Z71 CZC0044VYX CZC0070P76 CZC0070P79 CZC0070P7N CZC0133FN5 CZC0334KHV CZC0334KJ1 CZC0334KJ2 CZC0334KJ3 CZC0366ZR2 CZC0366ZR7 CZC0366ZR8 CZC0366ZRJ CZC0369HKH CZC0369HLB CZC0526KYT CZC1027W8G CZC1069WFN CZC9451GNV
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF SERBIA, PORTUGAL, POLAND, PARAGUAY, NORWAY, NETHERLANDS, NEPAL, MEXICO, MALAYSIA, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BOSNIA AND HERZEGOVINA, BELGIUM, BAHRAIN, AUSTRIA, and AUSTRALIA.
  • Product Description
    GE Healthcare, CARESCAPE Monitor B850. || Intended for use in multiple areas within a professional healthcare facility.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA