Panoramic Corporation PC-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00862309000309), received between Nov 18, 2016 and Jun 13, 2018 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K870236); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2018Mechanical Problem; Device Operational Issue; Unintended Movement; Mechanical Problem; Device Operational Issue; Unintended Movement

  DR. (B)(6) NOTIFIED US BE EMAIL ON (B)(6) 2018 THAT THREE WEEKS PRIOR (1ST WEEK OF (B)(6)APPROXIMATELY), A PATIENT WAS ENTERING THE UNIT AND THE SCREW MOTOR ASSEMBLY FAILED. THE OVERHEAD CHASSIS MADE CONTACT WITH THE PATIENT. ON (B)(6) 2018, THE DOCTOR GAVE US THE SERIAL NUMBER AND OTHER REQUIRED INFORMATION FOR THIS INCIDENT SO WE COULD INVESTIGATE AND CREATE A CASE. THE SCREW MOTOR IS STUCK NOW AND WILL NOT GO UP. THE PATIENT WAS SCRAPED ON THE CHEEK AND SHOULDER. THE PATIENT WAS TREATED WITH ANTIBIOTIC AND A BAND-AID ON THE CHEEK.

  Patient problems: Abrasion

  MAUDE report 7598026 ↗
• MalfunctionOct 12, 2017Human Factors Issue; Misassembly by Users; Device Handling Problem; Human Factors Issue; Misassembly by Users; Device Handling Problem

  ON 2017-09-24: A THIRD PARTY TECHNICIAN CALLED IN ABOUT (B)(4) AND STATED THAT OFFICE HAD FLOODED BUT NOT IN THE ROOM THAT THE MACHINE WAS IN. SO THEY MOVED THE MACHINE AND MOVED IT BACK. THE MACHINE MAKES A LOUD GRINDING NOISE WHEN RAISING AND LOWERING. THERE HAS BEEN A REPORT OF SN (B)(4) PC-1000 FALLING ON AN OFFICE STAFF MEMBER TWICE. THE FIRST TIME WAS AFTER THE MACHINE WAS MOVED OUT OF AND BACK INTO THE ROOM. THE SECOND TIME WAS AFTER THE THIRD PARTY TECHNICIAN SERVICED THE MACHINE AND TOLD THE OFFICE MANAGER, THAT "EVEN THOUGH IT IS NOISY AND GRINDING IT IS SAFE TO USE THE MACHINE". THE PERSON REPORTING THIS SITUATION WAS STAFF MEMBER (B)(4) AND RDH (HYGIENIST) AND (B)(4), THE OFFICE MANAGER. THE PERSON THAT THE MACHINE ALLEGEDLY FELL ON WAS STAFF MEMBER (B)(6). (B)(6) WAS NOT PRESENT AT THE TIME OF THE SERVICE VISIT. CALLED OFFICE TO GET MORE INFORMATION REGARDING (B)(6) AND WHETHER OR NOT THEIR WAS AN INJURY AND COULD NOT GET TO ANY PERSON DUE TO THE OFFICE BEING CLOSED. ON 2017-09-29: (B)(4) FROM (B)(4) CONFIRMED NO INJURY TO ANY STAFF MEMBERS DURING THIS RELOCATION OR AFTER BY UNCERTIFIED TECHNICIAN. CONFIRMED THAT NO ONE WAS HIT BY THE MACHINE OR INJURED IN ANY WAY AND

  Patient problems: No Patient Involvement

  MAUDE report 6945430 ↗
• InjuryMar 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2017, (B)(6) CALLED IN AND SAID THAT THE MACHINE WAS DRIFTING DOWN WITH A PATIENT POSITIONED IN THE MACHINE. THE PATIENT WAS INJURED BUT THE MACHINE DID DRIFT AWAY FROM WHERE THEY WERE POSITIONED AND THE HEAD SUPPORT MAY HAVE MADE CONTACT WITH THE TOP OF THE PATIENT'S HEAD. NO PATIENT INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6418106 ↗
• InjuryJan 25, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  * A RECALL FOR THIS ISSUE WAS INITIATED ON 23-APR-2015. DR (B)(6) CALLED AND STATED THAT HIS PC-1000 SERIAL NUMBER (B)(4) CAME DOWN AND HIT HIS EMPLOYEE IN THE HEAD ABOUT 7-10 DAYS AGO. SHE WENT OT THE HOSPITAL AND RECEIVED AN MRI AND CT SCAN. IT WAS REPORTED THAT SHE HAS NO BROKEN BONES ONLY BRUISES ACROSS HER BACK, NECK AND SIDE OF HER FACE. THE MACHINE 10729 WAS SOLD AND MOVED TO DR (B)(6) PRACTICE. HE WAS UNAWARE OF THE RECALL.

  Patient problems: Bruise/Contusion

  MAUDE report 6277761 ↗
• MalfunctionDec 9, 2016Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement

  RECEIVED A EMAIL FROM A CUSTOMER ABOUT THEIR MACHINE DRIFTING DOWN. THE MACHINE WILL KEEP DRIFTING DOWN ONCE THE HEIGHT IS SET UNTIL IT REACHES THE PATIENT'S SHOULDERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6157780 ↗
• MalfunctionDec 9, 2016Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement

  RECEIVED A VOICEMAIL FROM A CUSTOMER ABOUT THEIR MACHINE DRIFTING DOWN ONTO A PATIENT'S SHOULDERS. THE OFFICE REPRESENTATIVE STATED "THEY SET THE HEIGHT OF THE MACHINE , THEY POSITION THE PATIENT'S HEAD AND BY THE TIME THE X-RAY WAS DONE THE PATIENT WAS STARTING TO SQUAT. THE REPRESENTATIVE STATED THAT THE DRIFT WAS SLOW AND WOULD NOT CAUSE INJURY TO A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6157702 ↗
• MalfunctionNov 18, 2016Mechanical Problem; Device Operational Issue; Maintenance Does Not Comply To Manufacturers Recommendations; Mechanical Problem; Device Operational Issue; Maintenance Does Not Comply To Manufacturers Recommendations

  IN SUPPORT OF THE 2016 CORRECTION A FIELD SERVICE TECHNICIAN WAS SENT IN TO INSPECT THE SAFETY MECHANISM OF TWO MACHINES. HE WAS UNABLE TO INSPECT ONE MACHINE BECAUSE THE SHAFT WOULD NOT SPIN AND THE MACHINE WOULD NOT TRAVEL UP/DOWN. SINCE THIS PROBLEM WAS NOT REPORTED WHEN THE INSPECTION WAS SETUP THE TECHNICIAN DID NOT HAVE PARTS TO REPAIR THE MACHINE AND WOULD HAVE TO RETURN TO REPAIR THE MACHINE. THE REPAIR WAS SCHEDULE AND PERFORMED ON (B)(6) 2016. DURING THE REPAIR IT WAS DETERMINED THAT THE SCREW MOTOR HAD FAILED AND THE UNIT WAS SUPPORTED BY THE SAFETY NUT.

  Patient problems: No Information

  MAUDE report 6114113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K870236. One submission often covers many models, so check the product and lot details in each record.

• Z-0517-2018 · Jul 14, 2017 · Terminated
  PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
• Z-0016-2017 · Aug 19, 2016 · Terminated
  Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the u
• Z-2538-2015 · Jun 4, 2015 · Terminated
  Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well a