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Spacelabs Healthcare
SPACELABS HEALTHCARE (WASHINGTON), INC · Model EVENTREC · UDI-DI 10841522106934
DXH
Prescription
10
510(k) clearances
72
Adverse events (4 deaths)
10
Recalls
82
Facilities
Description
CARDIOCALL VS20,ENGLISH PROGRAMMABLE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | GE Medical Systems China Co., Ltd. | Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. |
| 2015-09-03 | Spacelabs Healthcare Inc | When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. T |
| 2015-01-09 | Alivecor SFO | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.