FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies: Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.
- Recall number
- Z-1015-04
- Recalling firm
- GE Medical Systems Information Technologies
- Product
- Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.
- Status
- Terminated
- Initiated
- 2004-01-27
- Posted
- 2004-07-20
- Terminated
- 2009-10-05
- Reason
- The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
- Root cause
- Other
- Action
- The firm mailed an 'Urgent Medical Device Correction' letter to consignees on January 27, 2004 advising them of the external electrical noise problem and informing them to not use the Dinalink ILC1931 with patients with pace makers until a fix or replacement can be provided. By 5/17/2004 corrective replacement cables had been provided to all consignees.
- Quantity
- 36
- Distribution
- Product was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY.
- Lot, serial or model codes
- No serial numbers but the Dinalink protocol converter and cable has the product identifier of ''ILC1931''
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1030184
- Firm city
- Tampa
- Firm state
- FL
- 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