Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmJune 16, 2005
Date PostedAugust 06, 2005
Recall Status1 Terminated 3 on October 05, 2005
Recall NumberZ-1104-05
Recall Event ID 32617
510(K)NumberK031760 
Product Classification Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) - Product Code DRT
ProductPanorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
Code Information All units currently out in the market.
FEI Number 2221819
Recalling Firm/
Manufacturer		 Datascope Corp
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information ContactSusan E. Mandy
201-995-8025
Manufacturer Reason
for Recall		Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
FDA Determined
Cause 2		Other
ActionThe firm sent a field correction communications to all customers via certified mail on 6/10/2005. A Datascope Service Representative will conduct and document this corrective action during a visit to the customer.
Quantity in Commerce70 units
DistributionThere were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DRT
-
-