The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1059-2014·Announced 2014-02-26

Elekta Synergy XVI Radiation Therapy System Recalled for Table Position Error

Elekta is recalling Synergy XVI radiation therapy systems because a software error can cause the treatment table to move to an incorrect position during specific online registration procedures.

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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by the risk of incorrect radiation delivery) fall under the 'Severe' category (Score 4).

Plain-English summary

Elekta, Inc. is recalling 1,028 units of the Synergy XVI radiation therapy system. The recall is due to a software error that can cause the system to incorrectly calculate the target position of the treatment table. This error occurs infrequently and is triggered by a specific sequence of events involving online VolumeView acquisition and registration. When the error occurs, the 'Relative Actual' column in the Table Move Assistant dialog box appears blank, causing the system to calculate table movements from the zero position rather than the actual position. This can result in the treatment table moving to an incorrectly calculated position when automatic setup buttons are pressed.

The affected software versions are 4.5, 4.5.1, 4.6, and 5.0. The units were distributed worldwide, including the United States (nationwide, including Puerto Rico and DC) and numerous international countries. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.

Healthcare facilities using the Synergy XVI system should contact Elekta, Inc. for instructions on how to resolve the issue. Patients who have received treatment on these systems should consult their healthcare provider if they have concerns about their treatment history.

The recalled product

Product
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept…
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
1,028

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 (4)

  • Model 4.5
  • 4.5.1
  • 4.6
  • 5.0

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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