Panoramic X-ray Model PC-1000 recallZ-2538-2015 · Panoramic Rental Corp. · initiated Jun 4, 2015
Class II Terminated All recalls posted in September 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Panoramic Rental Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
FDA root cause category: Equipment maintenance
What the company is doing
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.
Recall details
- Recall number
- Z-2538-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 4, 2015
- Posted by the FDA
- Sep 1, 2015
- Recalling firm
- Panoramic Rental Corp.
- Quantity
- 7885
- Product code
- EHD
- FDA submissions
- K870236, K882436
- 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 description
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.
Code information (models, lots, serial numbers)
Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
Other devices under the same FDA submission
2 devices cleared under K870236, K882436 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Panoramic Corporation PC-1000Young Ps Acquisition, LLC · Unit, X-Ray, Extraoral With Timer7 reports
- Panoramic Corporation PC-1000/Laser 1000Young Ps Acquisition, LLC · Unit, X-Ray, Extraoral With Timer5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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