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ZOLL RescueNet Link
Zoll Medical Corporation · Model LINKBASE · UDI-DI 00847946021948
10
510(k) clearances
325
Adverse events (98 deaths)
23
Recalls
73
Facilities
Description
Stand alone software EMS data system that electronically captures and displays patient monitoring, charting and navigation information related to the ambulance.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2025-11-18 | Mindray DS USA, Inc. dba Mindray North America | When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. |
| 2024-02-28 | Philips North America | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. |
| 2022-01-03 | Philips North America Llc | eCareManager (eCM) Sentry Score software not approved for use |
| 2021-05-27 | Mindray DS USA, Inc. dba Mindray North America | Telepack may not power on when using the 3AA battery cradle. |
| 2021-02-22 | Mindray DS USA, Inc. dba Mindray North America | BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no |
| 2018-01-17 | Spacelabs Healthcare Inc | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. |
| 2017-09-28 | Philips Electronics North America Corporation | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram |
| 2017-07-14 | Mindray DS USA, Inc. dba Mindray North America | A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate. |
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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.