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PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System
MEDICALGORITHMICS S A · Model Type: PECGT-IIIR · UDI-DI 05903021560056
1
510(k) clearances
32,636
Adverse events (1,917 deaths)
293
Recalls
118
Facilities
Description
The PocketECG CRS transmitter type PECGT-IIIR is a key component of PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG CRS transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. The PocketECG CRS is inteded for use in GSM cellular networks.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-08 | Nihon Kohden America LLC | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds |
| 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 |
| 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 |
| 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 |
| 2026-07-31 | Philips North America | Due to software malfunction, patient information system may freeze and become unresponsive. |
| 2026-07-31 | Philips North America | Due to software malfunction, patient information system may freeze and become unresponsive. |
| 2026-06-05 | Philips North America Llc | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI |
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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.