Access Cardiosystems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 9
At a glance
Market reach
- United States
- FDA recalls
What Access Cardiosystems, Inc. makes
Access Cardiosystems, Inc. manufactures manual defibrillators and semi-automatic external defibrillators (AEDs) designed for emergency cardiac resuscitation. These devices are intended for use by trained responders to deliver electrical shocks to restore normal heart rhythms in patients experiencing sudden cardiac arrest.
The company’s products are regulated under FDA Class II and Class III classifications, with relevant devices authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Access Cardiosystems Manual Defibrillator Ref K011461
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 9 recalls initiated by Access Cardiosystems, Inc., the earliest on 2003-12-19 and the most recent on 2004-11-03. By recorded status: 9 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 3 Nov 2004 Z-0199-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
- 3 Nov 2004 Z-0200-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
- 3 Nov 2004 Z-0201-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
- 3 Nov 2004 Z-0202-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
- 3 Nov 2004 Z-0203-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
- 3 Nov 2004 Z-0204-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
- 3 Nov 2004 Z-0205-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
- 3 Nov 2004 Z-0206-05 Unclassified (pre-2012) Terminated Device may fail to deliver shock due to a faulty circuit board
2003
- 19 Dec 2003 Z-0356-04 Unclassified (pre-2012) Terminated Difibrillator may fail to operate due to a faulty component on the circuit board
Frequently asked questions
How many devices does Access Cardiosystems, Inc. have in the registry?
The registry currently lists 2 devices for Access Cardiosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Access Cardiosystems, Inc.'s devices?
Among its 2 most recently registered devices, Access Cardiosystems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Access Cardiosystems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Access Cardiosystems, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Access Cardiosystems, Inc.?
FDA recall records list 9 recalls initiated by Access Cardiosystems, Inc., the most recent initiated on 3 Nov 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Access Cardiosystems, Inc. in the registry?
The most recently registered devices listed for Access Cardiosystems, Inc. include ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR and ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS.