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 SlimLine

  • 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 SlimLine see related information
Date Initiated by Firm June 18, 2008
Date Posted June 23, 2009
Recall Status1 Terminated 3 on July 06, 2012
Recall Number Z-1423-2009
Recall Event ID 51716
Product Classification body chamber - Product Code ISA
Product Sybaritic, Inc., SlimLine Health Environment Capsule,
a dry heat body chamber with facial and body chamber LED panels.
Code Information Serial Number 2109257
Recalling Firm/
Manufacturer		 Sybaritic, Inc
9220 James Ave S
Bloomington MN 55431-2302
For Additional Information Contact
952-888-8282
Manufacturer Reason
for Recall		 Misbranded and sale without pre-market notification.
FDA Determined
Cause 2		 PMA
Action Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA.
Quantity in Commerce 1
Distribution UT
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.
-
-