Z-0266-2020Class II

Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon...

Name: Z-0266-2020 Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon...
Creator: Datascope Corp.
Published: 2019-10-03
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2019-10-03 / Terminated / root cause: packaging

FDA source

Datascope Corp. began a recall of 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 on 2019-10-03. FDA classified it as Class II and gives the reason as "One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0266-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-03
Posted: 2019-11-01
Terminated: 2021-01-08
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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: 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 tag: packaging
FDA 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 [email protected] 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 in commerce: 7
Distribution: Distributed to CA, GA, and TX.
Product codes and lots: 10000493876

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0266-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0266-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01

Product code MHX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)