• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Agfa HeartLab Cardiovascular DICOMstore

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


New Search Back to Search Results
 Class 2 Recall
Agfa HeartLab Cardiovascular DICOMstore
see related information
Date Posted June 27, 2008
Recall Status1 Terminated on August 04, 2008
Recall Number Z-1241-2008
Recall Event ID 46381
Premarket Notification
510(K) Number
K050228 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
Code Information DICOMstore, L9M8E, Software version: 2.04.40.00
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
864-828-1827
Manufacturer Reason
for Recall
MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
Action On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an "Urgent Medical Device Correction" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.
Quantity in Commerce 43 units
Distribution Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
-
-