Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended

FDA device recall Z-1607-2015 · posted 2015-05-13 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.

Action taken

Philips sent an Urgent - Medical Device Correction letter dated March 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested their customers to do the following: " If a misalignment on the top and/or bottom of the guide rail between the cabinet and carriage can be visually detected do not continue with the collimator exchange procedure, " If the misalignment is visually detected, be aware that the customer/user cannot remedy this issue and will require service interaction prior to the continued use of the system. " This letter should be placed in your User Documentation until otherwise notified. If you need any further information or support concerning this issue, please contact your local Philips Healthcare representative: For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter site ID or follow the prompts).

Root cause

Device Design

Status

Terminated

Product code

LMC

Quantity affected

975 units

Distribution

Worldwide Distribution - US (nationwide) to the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, P

Date initiated

2015-03-11

Date posted

2015-05-13

Date terminated

2018-06-26

Location

Cleveland, OH