Esaote brand Formul@ ECG System; part 9704220000.
FDA device recall Z-0535-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Esaote Biomedica S.P.A.
- Reason for recall
- If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.
- Action taken
- A recall letter dated December 23, 2003 was sent to distributors asking them for contact information for affected customers. Esaote will the provide the user customers with an addendum to the users manual until a software upgrade becomes available and is installed.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 2
- Distribution
- California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
- Date initiated
- 2003-12-23
- Date posted
- 2004-07-20
- Date terminated
- 2004-10-28
- Location
- Indianapolis, IN
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