PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
FDA device recall Z-0517-2018 · posted 2018-01-09 · Terminated
Recall details
- Recalling firm
- Panoramic Rental Corp.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- EHD
- Quantity affected
- 13,340 units
- Distribution
- US Nationwide distribution including Puerto Rico
- Date initiated
- 2017-07-14
- Date posted
- 2018-01-09
- Date terminated
- 2018-07-23
- Location
- Fort Wayne, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LASER - 1000 (K882436) | Panoramic Corp. | 1988-08-04 |
| PANORAMIC X-RAY MODEL PC-1000 (K870236) | Panoramic Corp. | 1987-02-13 |