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 Zoll Medical

  • 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 Recall Zoll Medicalsee related information
Date Initiated by FirmAugust 02, 2004
Date PostedSeptember 17, 2004
Recall Status1 Terminated 3 on February 13, 2017
Recall NumberZ-1472-04
Recall Event ID 29959
510(K)NumberK010257 
Product Classification Hepatitis Viral B Dna Detection - Product Code MKT
ProductZoll M Series Automated Defibrillator (AED)
Code Information Software Versions below 34.00
Recalling Firm/
Manufacturer		 Zoll Medical Corporation
269 Mill Rd
Chelmsford MA 01824-4105
For Additional Information ContactPaul Dias
978-421-9413
Manufacturer Reason
for Recall		Visual Sreen display and audible prompt may not advise to 'Press Shock'
FDA Determined
Cause 2		Other
ActionZoll Medical notified consignees by letter on 8/2/04 via Certified Mail. Users are advised of the problem and the softtware upgrade.
Quantity in Commerce5649 units
DistributionNationwide
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 = MKT
-
-