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 Panoramic Xray Model PC1000, Laser1000

  • 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 Panoramic Xray Model PC1000, Laser1000 see related information
Date Initiated by Firm July 14, 2017
Date Posted January 09, 2018
Recall Status1 Terminated 3 on July 23, 2018
Recall Number Z-0517-2018
Recall Event ID 78105
510(K)Number K870236  K882436  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
Code Information Serial Numbers: 6001 to 19340
Recalling Firm/
Manufacturer		 Panoramic Rental Corp.
4321 Goshen Rd
Fort Wayne IN 46818-1201
Manufacturer Reason
for Recall		 The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.
FDA Determined
Cause 2		 Device Design
Action On July 14, 2017, Panoramic distributed Urgent Medical Device Correction notices to customers who own and have not taken action as required for the PC-1000 X-ray system machines. This means that your device does not have a critical safety feature that is intended to protect your patients and staff from harm. Customers are encouraged to immediately discontinue use of their machine and follow the instructions in the notice. Customers are encouraged to not resume use of the machine until a certified Panoramic service technician repairs the lift motor. Customers are advised to contact Panoramic to ensure any safety risks associated with the lift motor are identified and addressed. Action Required: (A) If your PC1000 machine is still in service at this location, you must immediately discontinue use and choose one of the following by returning the Acknowledgement Form or contacting the Panoramic Service Team by calling 888-381-2577 Monday through Friday 8 am - 6 pm. 1. An upgraded lift motor assembly at no cost to you; 2. A digital Panoramic rental unit to replace your PC1000, contingent on a signed one year rental contract (subject to availability); or 3. A new digital Panoramic or PanoramicCephalometric unit to replace your PC1000 at a reduced price (starting at $17,995 depending on machine type and subject to availability) (B) If your PC1000 machine is no longer in service or under your control: 4. If the machine is no longer in service, Panoramic will provide free removal of your machine.
Quantity in Commerce 13,340 units
Distribution US Nationwide distribution including Puerto Rico
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.
510(K) Database 510(K)s with Product Code = EHD and Original Applicant = PANORAMIC CORP.
-
-