FDA Device recall Z-0807-2014
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient…
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient… by Ge Healthcare, citing intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respira….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0807-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-05 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctors office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICU), pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output nad respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: Electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, CO2 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of GE Healthcare Page 3 of 6 monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and /or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The solar 8000i patient monitoring system also provides physiological data over the Unity Network.
Reason
Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
Identifiers
| code_info | Serial Number SA308044521GR SA308186360GA SA310444859GA SA308186380GA SA312091241GA SA308491207GA SA308186401GA…Serial Number SA308044521GR SA308186360GA SA310444859GA SA308186380GA SA312091241GA SA308491207GA SA308186401GA SA308186385GA SA308186374GA SA308155957GA SA308186391GA SA308186366GA SA308186410GA SA308094871GA SA308094818GA SA308186445GA SA308186381GA SA312479810GA SA308094940GA SA308094803GA SA308094872GA SA308084770GA SA310528992GA SA310506733GA SA310506696GA SA311153223GA SA311142931GA SA312080647GA SA312080894GA SA308186396GA SA308166121GA SA308186397GA SA308094807GA SA308186404GA SA311153169GA SA308186377GA SA308398894GA SA312253398GA SA308094809GA SA309263954GA SA310048616GA SA309527962GA SA310038386GA SA310048604GA SA310048613GA SA310028273GA SA310038462GA SA308317172GA SA311184814GA SA309365237GR SA311142946GA SA307332233GA SA307231341GA SA312069693GA SA309456714GA SA311163858GA SA312049242GA SA311317628GA SA307423146GA SA310259886GA SA309142960GA SA309334557GA SA307393020GA SA307453540GA SA307210827GA SA31201886 |
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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-0807-2014%22
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