Z-0016-2017Class II

Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate

Name: Z-0016-2017 Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate
Creator: Panoramic Rental Corp.
Published: 2016-08-19
License: https://open.fda.gov/license/

Panoramic Rental Corp. / initiated 2016-08-19 / Terminated / root cause: design

FDA source

Panoramic Rental Corp. began a recall of 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... on 2016-08-19. FDA classified it as Class II and gives the reason as "Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0016-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-19
Posted: 2016-10-04
Terminated: 2018-01-11
Recalling firm: Panoramic Rental Corp.
Product: 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 user to take panoramic x-ray images as well as cephalometric x-ray images.
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
Root cause tag: design
FDA root cause: Device Design
Action: Panoramic Corporation sent an Urgent Medical Device Correction letter dated August 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form and return to Panoramic. For questions contact Panoramic at [email protected] or 888-381-2577 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST in order to verify the effectiveness of the safety component.
Quantity in commerce: 13,340
Distribution: US Nationwide Distribution including Puerto Rico
Product codes and lots: Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0016-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0016-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-03

Product code EHD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)