FDA Device Recall Z-0016-2017: Panoramic Rental Corp.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2017.

Recall Res Number

Z-0016-2017

Recalling Firm / Manufacturer

Panoramic Rental Corp.

FEI Number

1832462

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-08-19

Date Posted

N/A

Date Terminated

2018-01-11

Product Code

EHD

Event Number

75017

Product Quantity

13,340

Product Description Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Reason for Recall Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.

Action Details Panoramic Corporation sent an Urgent Medical Device Correction letter dated August 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form and return to Panoramic. For questions contact Panoramic at correction@pancorp.com or 888-381-2577 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST in order to verify the effectiveness of the safety component.

Distribution Pattern US Nationwide Distribution including Puerto Rico

Code Information / Serial Numbers Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340

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Medical Device Recall: Z-0016-2017

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer