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U.S. Department of Health and Human Services

Class 2 Device Recall n/a

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  Class 2 Device Recall n/a see related information
Date Initiated by Firm October 03, 2019
Create Date November 01, 2019
Recall Status1 Terminated 3 on January 08, 2021
Recall Number Z-0266-2020
Recall Event ID 83927
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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
Code Information 10000493876
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Datascope/Getinge Customer Service
888-627-8383
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 7
Distribution Distributed to CA, GA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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