Access Cardiosystems, Inc.
Concord, MA, US
Access Cardiosystems, Inc. appears in FDA device records in Concord, MA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 9 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Access Cardiosystems, Inc. in 2002.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 2 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0206-05 | AccessAED PAD Package (without ECG trace) Model Number: 9100-0015-0 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0205-05 | AccessAED PAD (without ECG trace) -Public Access Defibrillator Model Number: 9100-0010-0 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0204-05 | AccessALS Package Model Number: 9100-0150-2 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0203-05 | AccessALS (Advanced Life Support) Model Number: 9100-0100-2 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0202-05 | AccessAED Package (with audio record) Model Number: 9100-0150-1 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0201-05 | AccessAED (with audio record) Model Number: 9100-0100-1 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0200-05 | AccessAED Package (without audio record) Model Number: 9100-0150-0 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0199-05 | AccessAED (without audio record) Model Number: 9100-0100-0 | Device may fail to deliver shock due to a faulty circuit board | Terminated | ||
| Z-0356-04 | Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100 | Difibrillator may fail to operate due to a faulty component on the circuit board | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain