| | Class 2 Device Recall RayStation |  |
| Date Initiated by Firm | February 11, 2022 |
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| Create Date | March 31, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0850-2022 |
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| Recall Event ID |
89822 |
| 510(K)Number | K211867 |
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| Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
| Product | RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs:
RayStation 4.0 (4.0.0.14) to
RayStation 5 Service Pack 2 (5.0.2.35),
RayStation 5 Service Pack 3 (5.0.3.17),
RayStation 6/RayPlan 2 (6.0.0.24),
RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2),
RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7),
RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6),
RayStation/RayPlan 7 (7.0.0.19),
RayStation/RayPlan 8A (8.0.0.61),
RayStation/RayPlan 8A Service Pack 1 (8.0.1.10)
Software versions: 4.0.0.14, 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 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, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 10.1.1.54, 11.0.0.951, 11.0.1.29, 11.0.3.116 or 12.0.0.932 |
|---|
| Code Information |
UDI # 07350002010020,
07350002010013,
07350002010082,
07350002010075,
07350002010242,
07350002010068,
07350002010112,
07350002010136,
07350002010129,
07350002010204,
07350002010235,
07350002010174,
07350002010266,
07350002010297,
07350002010303,
07350002010365,
07350002010310,
07350002010471,
07350002010389,
07350002010433,
07350002010440,
07350002010426 |
| FEI Number |
3010034862
|
Recalling Firm/
Manufacturer |
RaySearch America Inc
350 5th Ave Ste 5000
The Empire State Building
New York NY 10118-0110
|
Manufacturer Reason
for Recall | Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | A field safety notice dated February 07, 2022 was issued via email on February 11, 2022 which includes work around instructions to make sure that the SSD value is correct. Identify affected product via software version number(s). Notify all users and acknowledge receipt of the notice. For more information contact quality@raysearchlabs.com. |
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| Quantity in Commerce | 653 (US 149, OUS 504) |
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| Distribution | US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI.
|
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = MUJ
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