FDA Medical Device Recalls (openFDA)
Mira, Inc.: MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.
- Recall number
- Z-1920-2010
- Recalling firm
- Mira, Inc.
- Product
- MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.
- Status
- Terminated
- Initiated
- 2010-04-08
- Posted
- 2010-06-29
- Terminated
- 2016-08-08
- Reason
- Devices distributed without an approved 510(k)
- Root cause
- PMA
- Action
- Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.
- Quantity
- 5 units
- Distribution
- Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.
- Lot, serial or model codes
- SER#W04712-1 SER# W04690-1 SER# 01-1205 SER# 02-0506 One Unit no Serial Number
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HPS
- Firm FEI
- 1218813
- Firm city
- Uxbridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28