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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94388

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 28, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
RAYSEARCH LABORATORIES AB

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 12

RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.

Z-1741-2024
Recall number
Z-1741-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201006820171130; GTIN: 07350002010068; Serial Numbers: 7.0.0.19; Expiration Date: 2022-10-04.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 2 of 12

RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.

Z-1742-2024
Recall number
Z-1742-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10 Software Revisions: RayStation/RayPlan 8A and 8A Service Pack 1; Expiration Date: 2023-10-04.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 3 of 12

RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.

Z-1743-2024
Recall number
Z-1743-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10; Expiration Date: 2024-06-05.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 4 of 12

RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.

Z-1744-2024
Recall number
Z-1744-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
63 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201017420190612 and 0735000201048820220420; GTIN: 07350002010174 and 07350002010488; Serial Numbers: 9.0.0.113 and 9.0.1.142; Expiration Date: 2027-12-15.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 5 of 12

RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.

Z-1745-2024
Recall number
Z-1745-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201026620191220 and 0735000201029720200310; GTIN: 07350002010266 and 07350002010297; Serial Numbers: 9.1.0.933 and 9.2.0.483; Expiration Date: 2025-03-31.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 6 of 12

RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.

Z-1746-2024
Recall number
Z-1746-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
213 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201030320200526, 0735000201036520200526 and 0735000201065520220608; GTIN: 07350002010303, 07350002010365 and 07350002010655; Serial Numbers: 10.0.0.1154, 10.0.1.52 and 10.0.2.10; Expiration Date: 2025-06-16.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 7 of 12

RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.

Z-1747-2024
Recall number
Z-1747-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201031020201216 and 0735000201047120220128; GTIN: 07350002010310 and 07350002010471; Serial Numbers: 10.1.0.613 and 10.1.1.54; Expiration Date: 2027-02-01.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 8 of 12

RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.

Z-1748-2024
Recall number
Z-1748-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616; GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631; Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15; Expiration Date: 2027-06-22.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 9 of 12

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.

Z-1749-2024
Recall number
Z-1749-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
66 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222; GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570; Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119; Expiration Date: 2028-03-20.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 10 of 12

RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.

Z-1750-2024
Recall number
Z-1750-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
128 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201054920220616, 0735000201067920221007 and 0735000201073020230913; GTIN: 07350002010549, 07350002010679 and 07350002010730; Serial Numbers: 13.0.0.1547, 13.1.0.144 and 13.1.1.89; Expiration Date: 2028-10-05.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 11 of 12

RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.

Z-1751-2024
Recall number
Z-1751-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
49 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201055620230630; GTIN: 07350002010556; Serial Numbers: 14.0.0.3338; Expiration Date: 2028-07-07.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

device · product 12 of 12

RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.

Z-1752-2024
Recall number
Z-1752-2024
Initiated
March 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for reported SSD to be too high.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for reported SSD to be too high.

Code information

UDI: 0735000201072320231213; GTIN: 07350002010723; Serial Numbers: 15.0.0.430; Expiration Date: 2028-12-21.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.