ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Class I - DangerousWhat Should You Do?
- Check if you have this product: System No. 10568605:100044 100078 100085 100088 100098 100135 100020 100025 100001 100002 100003 100004 100006 100007 100008 100009 100010 100011 100012 100013 100014 100016 100017 100019 100023 100024 100028 100029 100030 100031 100032 100033 100034 100035 100036 100037 100038 100039 100040 100041 100042 100045 100047 100049 100051 100052 100053 100054 100056 100058 100059 100060 100061 100062 100063 100065 100066 100068 100069 100070 100071 100072 100073 100074 100075 100077 100079 100080 100082 100086 100087 100089 100090 100091 100092 100093 100094 100099 100101 100103 100104 100106 100107 100108 100111 100112 100113 100114 100115 100118 100119 100120 100121 100123 100124 100125 100126 100127 100130 100131 100133 100136 100138 100140.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Product Codes/Lot Numbers:
System No. 10568605:100044 100078 100085 100088 100098 100135 100020 100025 100001 100002 100003 100004 100006 100007 100008 100009 100010 100011 100012 100013 100014 100016 100017 100019 100023 100024 100028 100029 100030 100031 100032 100033 100034 100035 100036 100037 100038 100039 100040 100041 100042 100045 100047 100049 100051 100052 100053 100054 100056 100058 100059 100060 100061 100062 100063 100065 100066 100068 100069 100070 100071 100072 100073 100074 100075 100077 100079 100080 100082 100086 100087 100089 100090 100091 100092 100093 100094 100099 100101 100103 100104 100106 100107 100108 100111 100112 100113 100114 100115 100118 100119 100120 100121 100123 100124 100125 100126 100127 100130 100131 100133 100136 100138 100140.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1077-2013
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.