CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
Panoramic X-ray recalled by Panoramic Rental
Panoramic Rental is recalling Panoramic X-ray, distributed nationwide in the US. The recall was initiated on 4 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2538-2015
- FDA event ID
- 71653
- Recalling firm
- Panoramic Rental, Fort Wayne, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jun 2015
- FDA classified
- 1 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 4 Jun 2015 | Recall initiated by company | |
| 1 Sep 2015 | Classified by FDA | +89 days |
| 9 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Panoramic X-ray recalled?
Yes. Panoramic Rental recalled Panoramic X-ray on 4 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2538-2015.
Why was it recalled?
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Which lots are affected?
Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Panoramic Rental
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PC-1000, PC-1000/Laser1000 recalled by Panoramic Rental | Panoramic Rental | Other | Nationwide |
| Device | CLASS II | Panoramic X-ray recalled by Panoramic Rental | Panoramic Rental | Other | Nationwide |
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| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |