Z-0517-2018Class II

PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3

Name: Z-0517-2018 PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
Creator: Panoramic Rental Corp.
Published: 2017-07-14
License: https://open.fda.gov/license/

Panoramic Rental Corp. / initiated 2017-07-14 / Terminated / root cause: design

FDA source

Panoramic Rental Corp. began a recall of PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 on 2017-07-14. FDA classified it as Class II and gives the reason as "The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule". 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-0517-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Posted: 2018-01-09
Terminated: 2018-07-23
Recalling firm: Panoramic Rental Corp.
Product: PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
Product code: EHD Unit, X-Ray, Extraoral With Timer
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Serial Numbers: 6001 to 19340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0517-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0517-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-04

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)