FDA Medical Device Recalls (openFDA)
Esaote Biomedica S.P.A.: Esaote brand Formula for Archimed ECG System; part 9704220000.
- Recall number
- Z-0533-04
- Recalling firm
- Esaote Biomedica S.P.A.
- Product
- Esaote brand Formula for Archimed ECG System; part 9704220000.
- Status
- Terminated
- Initiated
- 2003-12-23
- Posted
- 2004-07-20
- Terminated
- 2004-10-28
- Reason
- If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.
- Root cause
- Other
- Action
- 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.
- Quantity
- 20
- Distribution
- California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
- Lot, serial or model codes
- Serial numbers: 103, 106, 107, 108, 129, 135, 136, 197, 205, 242, 270, 348, 361, 373, 420, 441, 462, 464, 520 and 522.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- not on file
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28