e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or orga

FDA device recall Z-0914-2015 · posted 2015-01-06 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

There is a potential for patient finger injury on the e.cam systems.

Action taken

The firm, Siemens, sent a "Customer Safety Advisory Notice" letter dated April 8, 2014 to all direct accounts (customers). The letter described the product, problem and actions to be taken. The letter instructed the customers to follow the instructions in the e.cam operator's manual and the e.cam Patient Bed Safety Addendum of the operator's manual; and to always monitor the patient at all times while they are on the system during initiation of any system movement. The letter further requested that customers forward the letter to the new owner of the equipment in the event that the system is sold or transferred. Customers with questions about this letter can contact Siemens Medical Solutions USA at 800-888-7463 (Monday - Friday, 7:00 AM - 8:00 PM EST).

Root cause

Use error

Status

Terminated

Product code

KPS

Quantity affected

4,462 systems

Distribution

Worldwide Distribution: US (nationwide) including states of: AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN,

Date initiated

2014-04-08

Date posted

2015-01-06

Date terminated

2016-12-23

Location

Hoffman Estates, IL

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