FDA Medical Device Recalls (openFDA)
Carestream Health Inc: Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
- Recall number
- Z-2217-2016
- Recalling firm
- Carestream Health Inc
- Product
- Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
- Status
- Terminated
- Initiated
- 2016-07-08
- Posted
- 2016-07-18
- Terminated
- 2017-05-02
- Reason
- A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
- Root cause
- Software design
- Action
- The firm, Carestream Health Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter dated 7/7/2016 and response form the end users/customers on 7/8/2016 via Certified Mail, Return Receipt Requested. The letter described the product, problem and actions to be taken. The Customers were instructed not use the generic volume measurement tool until Carestream has updated the system software. In the interim, calculate volumes by using the specific volume tool from the desired calculation package. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact Carestream Customer Care Center as listed above. Carestream has created a software update for Touch Ultrasound to resolve this issue and will update your software. Carestreams representative will contact you and schedule a convenient time to upgrade the software. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910 (available on a 24/7 basis). Outside of the US, please call your local Service support number.
- Quantity
- 7 Units (US: 5 units, OUS: 2 units)
- Distribution
- Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
- Lot, serial or model codes
- Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043
- 510(k) numbers
- ["K152467"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1315356
- Firm city
- Rochester
- Firm state
- NY
- 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