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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

RAYSEARCH LABORATORIES AB: RayStation Radiation Therapy Planning Systems Recalled for Incorrect SSD Reports

Agency Publication Date: May 1, 2024
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Summary

RaySearch Laboratories AB is recalling 589 units of RayStation Radiation Therapy Treatment Planning Systems (various versions from 7.0 to 15.0) because the software may report Source-to-Surface Distance (SSD) values that are too high. This defect affects the planning and delivery of radiation treatments used for cancer patients. Consumers and healthcare providers should check their software version against the list of affected products to ensure treatment accuracy.

Risk

If the software reports an incorrect distance between the radiation source and the patient's skin, it could lead to inaccurate radiation dosing or improper placement of the treatment beam. This error creates a risk of under-dosing or over-dosing the patient during cancer therapy.

What You Should Do

  1. Identify if your facility is using an affected software version by checking the system information in RayStation for versions 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.0.1.142, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.0.2.10, 10.1.0.613, 10.1.1.54, 11.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15, 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, 12.3.0.119, 13.0.0.1547, 13.1.0.144, 13.1.1.89, 14.0.0.3338, or 15.0.0.430.
  2. Verify the Unique Device Identifier (UDI) and GTIN on your software license or packaging, such as GTINs 07350002010068, 07350002010112, 07350002010136, 07350002010174, 07350002010488, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010655, 07350002010310, 07350002010471, 07350002010389, 07350002010433, 07350002010440, 07350002010631, 07350002010426, 07350002010495, 07350002010501, 07350002010600, 07350002010570, 07350002010549, 07350002010679, 07350002010730, 07350002010556, or 07350002010723.
  3. Contact your healthcare provider or the manufacturer, RaySearch Laboratories AB, at their Stockholm headquarters (Eugeniavagen 18c) for technical guidance and to receive necessary software updates or patches.
  4. For further information or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer for further instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: RayStation 7.0.0.19 Radiation Therapy Treatment Planning System
Model / REF:
7.0.0.19
UPC Codes:
07350002010068
Lot Numbers:
UDI: 0735000201006820171130
Date Ranges: Expiration: 2022-10-04
Product: RayStation 8.0.0.61, 8.0.1.10 Radiation Therapy Treatment Planning System
Model / REF:
8.0.0.61
8.0.1.10
RayPlan 8A
8A Service Pack 1
UPC Codes:
07350002010112
07350002010136
Lot Numbers:
UDI: 0735000201011220180608
UDI: 0735000201013620180928
Date Ranges: Expiration: 2023-10-04
Product: RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5 Radiation Therapy Treatment Planning System
Model / REF:
8.1.0.47
8.1.1.8
8.1.2.5
UPC Codes:
07350002010112
07350002010136
Lot Numbers:
UDI: 0735000201011220180608
UDI: 0735000201013620180928
Date Ranges: Expiration: 2024-06-05
Product: RayStation 9.0.0.113 and 9.0.1.142 Radiation Therapy Treatment Planning System
Model / REF:
9.0.0.113
9.0.1.142
UPC Codes:
07350002010174
07350002010488
Lot Numbers:
UDI: 0735000201017420190612
UDI: 0735000201048820220420
Date Ranges: Expiration: 2027-12-15
Product: RayStation 9.1.0.933 and 9.2.0.483 Radiation Therapy Treatment Planning System
Model / REF:
9.1.0.933
9.2.0.483
UPC Codes:
07350002010266
07350002010297
Lot Numbers:
UDI: 0735000201026620191220
UDI: 0735000201029720200310
Date Ranges: Expiration: 2025-03-31
Product: RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10 Radiation Therapy Treatment Planning System
Model / REF:
10.0.0.1154
10.0.1.52
10.0.2.10
UPC Codes:
07350002010303
07350002010365
07350002010655
Lot Numbers:
UDI: 0735000201030320200526
UDI: 0735000201036520200526
UDI: 0735000201065520220608
Date Ranges: Expiration: 2025-06-16
Product: RayStation 10.1.0.613 and 10.1.1.54 Radiation Therapy Treatment Planning System
Model / REF:
10.1.0.613
10.1.1.54
UPC Codes:
07350002010310
07350002010471
Lot Numbers:
UDI: 0735000201031020201216
UDI: 0735000201047120220128
Date Ranges: Expiration: 2027-02-01
Product: RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15 Radiation Therapy Treatment Planning System
Model / REF:
11.0.0.951
11.0.1.29
11.0.3.116
11.0.4.15
UPC Codes:
07350002010389
07350002010433
07350002010440
07350002010631
Lot Numbers:
UDI: 0735000201038920210518
UDI: 0735000201043320210610
UDI: 0735000201044020210916
UDI: 0735000201063120220616
Date Ranges: Expiration: 2027-06-22
Product: RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 & 12.3.0.119 Radiation Therapy Treatment Planning System
Model / REF:
12.0.0.932
12.1.0.1221
12.0.3.68
12.0.4.12
12.3.0.119
UPC Codes:
07350002010426
07350002010495
07350002010501
07350002010600
07350002010570
Lot Numbers:
UDI: 0735000201042620211208
UDI: 0735000201049520220312
UDI: 0735000201050120220422
UDI: 0735000201060020220620
UDI: 0735000201057020221222
Date Ranges: Expiration: 2028-03-20
Product: RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89 Radiation Therapy Treatment Planning System
Model / REF:
13.0.0.1547
13.1.0.144
13.1.1.89
UPC Codes:
07350002010549
07350002010679
07350002010730
Lot Numbers:
UDI: 0735000201054920220616
UDI: 0735000201067920221007
UDI: 0735000201073020230913
Date Ranges: Expiration: 2028-10-05
Product: RayStation 14.0.0.3338 Radiation Therapy Treatment Planning System
Model / REF:
14.0.0.3338
UPC Codes:
07350002010556
Lot Numbers:
UDI: 0735000201055620230630
Date Ranges: Expiration: 2028-07-07
Product: RayStation 15.0.0.430 Radiation Therapy Treatment Planning System
Model / REF:
15.0.0.430
UPC Codes:
07350002010723
Lot Numbers:
UDI: 0735000201072320231213
Date Ranges: Expiration: 2028-12-21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94388
Status: Active
Manufacturer: RAYSEARCH LABORATORIES AB
Sold By: Authorized distributors
Manufactured In: Sweden
Units Affected: 12 products (14 units; 9 units; 5 units; 63 units; 11 units; 213 units; 18 units; 10 units; 66 units; 128 units; 49 units; 3 units)
Distributed To: Nationwide

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.