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

FDA device recall Z-2538-2015 · posted 2015-09-01 · Terminated

Recall details

Recalling firm

Panoramic Rental Corp.

Reason for recall

Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.

Action taken

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 recall@pancorp.com 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.

Root cause

Equipment maintenance

Status

Terminated

Product code

EHD

Quantity affected

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, Gree

Date initiated

2015-06-04

Date posted

2015-09-01

Date terminated

2017-05-30

Location

Fort Wayne, IN

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