Class 2 Device Recall SKYLight Imaging Systems

• Date Initiated by Firm: December 08, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on August 13, 2012
• Recall Number: Z-0607-2012
• Recall Event ID: 60660
• 510(K)Number: K000908
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: SKYLight Imaging Systems, Model 882050;; ; Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
• Code Information: Model numberL 882050; Code numbers: K01110023 K02040041, K02050049 K03050121 K02030032 K01070004 K02080079 K02100095 K02030033 K02030034 K01070003 K02070068 K02080075, K02080082 K01090015 K01080005 K02080077 K01080009 K01100016 K02050058 K02070065 K02080078 K02030035 K02070070 K01100019 K01110027 K01110021 K02100092 K02090087 K02060061 K03060124 K02040040 K02030037 K02100094 K02070063 K01100017 K01110025 K02050052 K03080132 K02040043 K01090012 K03030112 K01100020, K02070064 K03070128 K03040115 K01080008 K02090084, K03030108 K02100098 K01110022 K01110024 K02050048 K02090088 K03050119 K03030107 K02050055 K01090011 K03060122 K02070062 K02040047 K01090010 K02050059 K03040116 K02050054 K03030109 K03080134 K02030038 K03080133 K02070072, K02080081 K02100091 K02060050 K02020029 K03030114 K02100096 K02070071 K03040117 K03060123 K01080006 K03030135 K03080135 K01080007 K02020030, K02040045 K02070067 K02020031 K03070125 K02030036 K02070066 K02090083 K02100090 K02090089 K02110097 K02120104 K02120106 K03070129 K03070130 K02080074 K02120105 K02040042 K03040118 K02110101 K02120103 K03050120 K02110102 K02110001 K03070131 K02050053 K03070126 K02040044 K03030113 K03030110 K03030111 K02070073 K02050056 K02110100 K02050050 K02040046 K01090013 K03070127 K01110028 K02050051 K02030039 K02080076 K02050057 K02090085
• Recalling Firm/ Manufacturer: Philips Medical Systems; 3860 N 1st St; San Jose CA 95134-1702
• For Additional Information Contact: Kumudini J. Carter; 408-468-3000
• Manufacturer Reason for Recall: During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Correction/Field Safety Notices, dated Dec 08, 2011, were mailed to affected customer sites on December 9th and 12th, 2011 by Return Receipt certified mail. The letter identified the affected product, described the issue and when it could occur, along with the hazards involved. Customers were advised to stop using the system and contact a Philips service representative for an immediate inspection. Customers were also to follow the Instructions For Use to avoid the issue. Philips service will contact customers to arrange a time for Philips to inspect the system. The letter should be placed in the Instructions for Use. The Field Change Order will be released on December 16, 2011. If further information or support is needed, customers should contact Customer Care Solutions Center at 1-800-722-9377.
• Quantity in Commerce: 129
• Distribution: Worldwide Distribution -- USA, Canada, Italy, Spain, France, United Kingdom, Sweden, Switzerland, Germany, Japan, Denmark, and the Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES