Dna Probe, Trichomonas Vaginalis
Microbiology · 21 CFR 866.2660
Recent MDR events
69 adverse event reports on file
- X SERIESFeb 18, 2026MalfunctionZoll Medical Corporation1220908-2026-00431
- R SERIESJan 28, 2026MalfunctionZoll Medical Corporation1220908-2026-00213
- HEARTSTARTFeb 21, 2025MalfunctionPhilips North America Llc3030677-2025-000557
- FRX DEFIBRILLATOR, FRENCH, EXCHANGEFeb 20, 2025MalfunctionPhilips North America Llc3030677-2025-000556
- PHILIPS HEARTSTART HOMEFeb 14, 2025MalfunctionPhilips North America Llc3030677-2025-000508
- POWERHEART G5 KIT, AUTO, SWE/INTL ENGNov 1, 2024MalfunctionCardiac Science Corporation2112020-2024-00861
- PAD, DEFIB, ADULT, RADIOTRANS, PHYSIOAug 29, 2024InjuryMedline Industries, Lp1417592-2024-00832
- POWERHEART G5 KIT,AUTO,DUT-INTL ENG,CPRDApr 1, 2024MalfunctionCardiac Science Corporation2112020-2024-00246
- POWERHEART G5 KIT, AUTO, INTL ENGOct 16, 2023MalfunctionCardiac Science Corporation2112020-2023-00931
- HS1+ (W G) DEFIB, JAPANESE, EXCHGAug 3, 2023MalfunctionPhilips North America Llc3030677-2023-03099
Event type breakdown
Recalls
6 recall events for this product code
- Physio Control, Inc.TerminatedSep 16, 2008
LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended
This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators h
Z-2341-2008 · View FDA record ↗ - Medtronic Emergency Response Systems, Inc.TerminatedJul 4, 2007
LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare pr
Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.
Z-0886-2007 · View FDA record ↗ - Medtronic Emergency Response Systems, Inc.TerminatedJul 4, 2007
Batteries used with the LIFEPAK 20 defibrillator/monitor
Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.
Z-0887-2007 · View FDA record ↗ - Medtronic Emergency Response Systems, Inc.TerminatedJun 9, 2007
LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare prov
White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.
Z-0925-2007 · View FDA record ↗ - MRL, Inc., A Welch Allyn CompanyTerminatedJan 19, 2007
Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Manufactured by
Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.
Z-0343-2007 · View FDA record ↗ - MRL, Inc., A Welch Allyn CompanyTerminatedJul 8, 2006
Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by
The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
Z-1195-06 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
1 clearances for this product code