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PocketECG IV - Unified Arrhythmia Diagnostic System
MEDICALGORITHMICS S A · Model P3HL-AB-UNI · UDI-DI 05903021560223
DSI
Prescription
1
510(k) clearances
33,431
Adverse events (508 deaths)
82
Recalls
119
Facilities
Description
The holster type P3HL-AB-UNI is an accessory to the PocketECG IV - Medicalgorithmics Unified Arrhythmia Diagnostic System. It is a belt holder for PocketECG transmitters (types P4TR-AA-ADS and P4TR-AB-ADS) for indoor use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-26 | Spacelabs Healthcare, Inc. | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). |
| 2026-02-27 | Spacelabs Healthcare, Inc. | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurem |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
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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.