Synergy XVI XVI can incorrectly calculate the target position of the… — Class II medical device recall Z-1059-2014
Terminated recall by Elekta, Inc., reported 2014-02-26, distributed nationwide. XVI can incorrectly calculate the target position of the treatment table.
| Recall number | Z-1059-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2014-02-20 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2017-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BH, BR, CA, CH, CN, CY, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IQ, IT, JO, JP, KR, MA, MX, MY, NL, NO, NZ, PK, PL, PT, RO, RU, SA, SE, SG, SI, TH, TR, TW, VE, ZA |
| Quantity | 1,028 |
| Model numbers | 4.5, 4.5.1, 4.6, 5.0 |
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 the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.
Reason for recall
XVI can incorrectly calculate the target position of the treatment table.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.