Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in th

FDA device recall Z-1250-2015 · posted 2015-03-06 · Terminated

Recall details

Recalling firm

Pivotal Health Solutions

Reason for recall

Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo product line.

Action taken

The firm, Pivotal Health Solutions, sent a letter dated December 17, 2014 on 12/17/2014 and an amended Pivotal "Urgent Medical Device Recall" letter dated February 9, 2015 to its consignees/customers. The letters described the product, problem and actions to be taken. The consignees/customers were instructed to stop using the unit and contact Pivotal Health Solution's at 1-800-743-7738 to arrange for return and repair asap; immediately examine your device inventory and quarantine any product subject to recall; if you have further distributed the product, identify your customers and notify them at once of this product recall, and complete and return the enclosed RETURN AUTHORIZATION FORM with the units to Pivotal Service Center, 1654 Mardon Drive, Dayton, OH 45432 and the DECLARATION OF CONTAMINATION STATUS form via Fax to: 605-882-8398. If you have any questions, contact Pivotal Health Solutions Service Repair Coordinator at 800-743-7738 or email Robin@PivotalHealthSolusitons.com.

Root cause

Device Design

Status

Terminated

Product code

ILY

Quantity affected

35

Distribution

US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.

Date initiated

2014-12-17

Date posted

2015-03-06

Date terminated

2016-03-09

Location

Watertown, SD

Related 510(k) clearances