The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1275-2018·Announced 2018-04-04

Ray Station Software Recalled for Potential Incorrect Radiation Treatment Volume

RaySearch Laboratories is recalling Ray Station 4.9 through 7 software due to a defect that may result in incorrect treatment volumes being delivered to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can result in incorrect radiation treatment volumes, posing a risk of significant injury to patients.

Plain-English summary

RaySearch Laboratories AB is recalling specific versions of its Ray Station software, including builds 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, and 7.0.0.19. The recall involves 2,484 units distributed nationwide. The software is used for radiation therapy planning.

The recall was initiated because of a software issue with the "Center Beam in Field" functionality. This defect can result in an incorrect treatment volume being delivered to a patient. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences.

Healthcare facilities and users of the affected software should contact RaySearch Laboratories AB for instructions on how to resolve the issue. Patients who have received treatment using the affected software versions should consult their healthcare providers to determine if their treatment plans were impacted.

The recalled product

Product
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
2,484

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Software build numbers: 4.9.0.42
  • 5.0.0.37
  • 5.0.1.11
  • 5.0.2.35
  • 6.0.0.24
  • 6.1.0.26
  • 6.1.1.2
  • 6.2.0.7 or 7.0.0.19

Distribution

Distributed nationwide across the United States.

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