FDA Medical Device Recalls (openFDA)
Datascope Corp.: Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03
- Recall number
- Z-0266-2020
- Recalling firm
- Datascope Corp.
- Product
- Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03
- Status
- Terminated
- Initiated
- 2019-10-03
- Posted
- not on file
- Terminated
- 2021-01-08
- Reason
- One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
- Root cause
- Under Investigation by firm
- Action
- On October 3, 2019, the firm notified customers of the recall via an Urgent Medical Device Recall letter. The letter alerted customers that the incorrect cable may have been supplied. Customers were asked to take the following actions: -Please examine your inventory immediately, remove and quarantine any affected product. - If you have unused affected product, please contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 1) between the hours of 8 AM and 6 PM Eastern Standard Time to request a material authorization number (RMA) and shipping instructions. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. Replacement product or a credit will be issued for your return. -Please enter the quantity and RMA number provided by Customer Service in the spaces provided on the URGENT MEDICAL DEVICE RECALL REMOVAL Response Form on Page 4 of the letter, if you are returning products to Datascope/Getinge. -Please complete and sign the attached URGENT MEDICAL DEVICE RECALL REMOVAL RESPONSE FORM (page 4) to acknowledge that you have received the notification. Return the completed form to Datascope/Getinge by emailing a scanned copy to marylou.insinga@getinge.com or by faxing the form to 1-973-807-9290. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Customer Service at 1-888-627-8383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Quantity
- 7
- Distribution
- Distributed to CA, GA, and TX.
- Lot, serial or model codes
- 10000493876
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3001418283
- Firm city
- Mahwah
- Firm state
- NJ
- 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