FDA recall Z-0952-2024

Product

Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

Reason for recall

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-01-03

Report date

2024-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2024