FDA Device recall Z-0489-2014
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Mo…
- FDA Device
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Mo… by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B4….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0489-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-11 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16,061 (343 US, 15,718 OUS)
Reason
GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The
Identifiers
| code_info | Mfg Lot or Serial # SG212501463WA SG213142063WA SG212491284WA SG212491286WA SG212491320WA SG212491328WA SG213091…Mfg Lot or Serial # SG212501463WA SG213142063WA SG212491284WA SG212491286WA SG212491320WA SG212491328WA SG213091890WA SG213142034WA SG213142065WA SG213172123WA SG213172126WA SG213172141WA SF311283756WA SF312205556WA SG212190622WA SG212190623WA SG212190624WA SG212190625WA SG212190626WA SG212190627WA SG212190628WA SG212190629WA SG212190630WA SG212190631WA SG212160603WA SG212160606WA SG212230660WA SG212260716WA SG212260735WA SG212260737WA SG212260739WA SG212270742WA SG212270747WA SG212491329WA SG212491346WA SG212421031WA SG212431128WA SG212421034WA SG213021574WA SG213031688WA SG212521557WA SG212521545WA SF312396183WA SF312396187WA SF312396189WA SF312396190WA SF312396191WA SF312396192WA SF312396193WA SG213142038WA SG212521547WA SG213021582WA SG213021585WA SG213031681WA SG213031683WA SG213031684WA SG213031685WA SG213031687WA SG213031689WA SF310200786WA SF310200788WA SG212521544WA SG212521546WA SG212521548WA SG212521549WA SG21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.