Type-S™ Extension MTCFHNVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841439104156), received between May 7, 2020 and Jun 24, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K933227); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 12, 2020Terminated

   Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.

   Z-2243-2020 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2020Detachment of Device or Device Component

  EXTENSION DISENGAGED FROM THE TABLE WHEN TWO THERAPISTS LIFTED THE PATIENT ON A SHEET WHILE THE PATIENT WAS UNDER A THERMOPLASTIC MASK. PATIENT WAS SUPPORTED BY THERAPISTS HOLDING SHEET AND DID NOT FALL. AFTER TAKING KV IMAGES, IT WAS DECIDED THAT THE PATIENT NEEDED ADJUSTMENT FOR PROPER ALIGNMENT FOR TREATMENT. THERAPISTS USED A SHEET UNDERNEATH THE PATIENT TO MOVE THE PATIENT SLIGHTLY FURTHER UP INTO THE HEAD, NECK, AND SHOULDER THERMOPLASTIC MASK AND WHILE DOING SO, THE EXTENSION DETACHED FROM THE COUCH. THE PATIENT STARTED TO FALL WITH THE EXTENSION BUT WAS CAUGHT BY THE THERAPISTS. THERE WERE NO INJURIES; THE PATIENT WAS JUST ALARMED AND SCARED DURING THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10189608 ↗
• InjuryMay 7, 2020Detachment of Device or Device Component

  EXTENSION DISENGAGED FROM THE TABLE WHEN TWO THERAPISTS LIFTED THE PATIENT ON A SHEET WHILE THE PATIENT WAS UNDER A THERMOPLASTIC MASK. PATIENT WAS SUPPORTED BY THERAPISTS HOLDING SHEET AND DID NOT FALL. AFTER TAKING KV IMAGES, IT WAS DECIDED THAT THE PATIENT NEEDED ADJUSTMENT FOR PROPER ALIGNMENT FOR TREATMENT. THERAPISTS USED A SHEET UNDERNEATH THE PATIENT TO MOVE THE PATIENT SLIGHTLY FURTHER UP INTO THE HEAD, NECK, AND SHOULDER THERMOPLASTIC MASK AND WHILE DOING SO, THE EXTENSION DETACHED FROM THE COUCH. THE PATIENT STARTED TO FALL WITH THE EXTENSION BUT WAS CAUGHT BY THE THERAPISTS. THERE WERE NO INJURIES; THE PATIENT WAS JUST ALARMED AND SCARED DURING THE INCIDENT.

  Patient problems: No Code Available

  MAUDE report 10034120 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933227. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2010 · Aug 31, 2009 · Terminated
  CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on