Z-2538-2015Class II

Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The...

Name: Z-2538-2015 Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The...
Creator: Panoramic Rental Corp.
Published: 2015-06-04
License: https://open.fda.gov/license/

Panoramic Rental Corp. / initiated 2015-06-04 / Terminated / root cause: manufacturing process

FDA source

Panoramic Rental Corp. began a recall of 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... on 2015-06-04. FDA classified it as Class II and gives the reason as "Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2538-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-09-01
Terminated: 2017-05-30
Recalling firm: Panoramic Rental Corp.
Product: 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 as cephalometric x-ray images.
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm, Panoramic Corporation, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 7/17/2015 via certified mail to customers on 7/20/2015, with response forms for customers to complete and return. The firm previously issued "IMPORTANT SERVICE BULLETIN" notices in 2003 and 2008 via FED-EX. The letter describes the product, problem and actions to be taken. The customers are instructed to select to use several options including replacing the failing part with one containing the safety feature, or trading in their machine for a newer one; discontinue using the devices immediately regardless the option you select, and complete and return the attached response card via email to [email protected] or fax to 260-489-5683. If the machine has been sold or donated to another dental outfit, the customer should notify Panoramic so that they can update their records. When the customer is reached, the firm will confirm whether or not the machine is still in service. Customers with questions may contact 800-654-2027 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST to discuss these options and determine which is best for their practice.
Quantity in commerce: 7885
Distribution: Worldwide distribution: US (nationwide) all 50 states, including Puerto Rico; and countries of Antigua, Armenia, Aruba, Austria, Canada, China, Colombia, Ecuador, Egypt, England, France, Germany, Greece, Haiti, Honduras, Indonesia, Japan, Kenya, Lithuania, Mexico, Panama, Saudi Arabia, Singapore, Taiwan, Turkey, UAE, Uganda, Venezuela, Vietnam, and Virgin Islands.
Product codes and lots: Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2538-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2538-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01

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)