Recall Z-2220-2017— Iba Dosimetry

Name: FDA recall Z-2220-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-26

Class II · Terminated

Class II FDA medical device recall by Iba Dosimetry, initiated 2017-04-26, terminated 2018-06-11. It names one FDA 510(k) clearance: K945321. Product: Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T. Reason: When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear..

Recalling firm: Iba Dosimetry
Classification: Class II
Status: Terminated
Initiated: 2017-04-26
Terminated: 2018-06-11
Firm location: Bartlett, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K945321 — WELLHOFER WP700 V. 3.2Medical Physics Instrumentation, Inc.·cleared 1995-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

Reason for recall

When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear.

Data sourced from openFDA. This site is unofficial and independent of the FDA.