Achieva Family

• 3 recalls, same reason

  • Ongoing Z-2165-2024 FDA Class I ·initiated 5 Jun 2024 ·on shared 510(k) K043147
  • Ongoing Z-2164-2024 FDA Class I ·initiated 5 Jun 2024 ·on shared 510(k) K043147
  • Ongoing Z-2163-2024 FDA Class I ·initiated 5 Jun 2024 ·on shared 510(k) K043147

  Potential for coils to heat up and harm patients (burn).

• 10 recalls, same reason

  • Terminated Z-0928-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0884-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0893-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0914-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0905-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0913-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0906-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0907-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0927-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0897-2019 FDA Class II ·initiated 21 Dec 2018

  There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K043147 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Tomoscan Stereotaxis Simulation Software

  Class II

  FDA 510(k) K900660 Active Cleared 13 Mar 1990

• Integris 3D-Ra, Release 4.2

  Class II

  FDA 510(k) K040254 Active Cleared 19 Feb 2004

• Ep Navigator R3

  Class II

  FDA 510(k) K101311 Active Cleared 30 Sep 2010

• Orthoralix Sd/Orthoralix Sd Ceph

  Class II

  FDA 510(k) K890351 Active Cleared 15 Jun 1989

• Doppler Option for Platinum

  Class II

  FDA 510(k) K900002 Active Cleared 2 Apr 1990

• Philips Bucky Diagnost Family

  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

See all devices from Philips Medical Systems North America, Inc. →

• What is the Achieva Family used for in clinical settings?

  The Achieva Family MRI Systems are designed to generate detailed images of the human body using strong magnetic fields and radio waves. These systems assist in diagnosing and monitoring a wide range of medical conditions, including neurological disorders (e.g., brain or spinal issues), cardiovascular problems (e.g., heart or blood vessel assessments), and musculoskeletal disorders (e.g., joint or bone abnormalities). Their advanced imaging capabilities enable precise visualization of soft tissues, organs, and skeletal structures, supporting accurate clinical evaluations.

• How is the Achieva Family supplied and intended for use?

  The Achieva Family MRI Systems are supplied as reusable medical equipment, intended exclusively for use in clinical environments such as hospitals and radiology centers. Unlike single-use devices, these systems require regular maintenance, calibration, and adherence to manufacturer guidelines to ensure safe and reliable operation. Their design supports long-term clinical use in MRI-safe environments, adhering to strict electromagnetic compatibility and safety standards.

• Are there multiple models in the Achieva Family, and how are they differentiated?

  Yes, the Achieva Family includes multiple model variants, each corresponding to specific registration numbers and technical configurations. These models are differentiated by their unique identifiers (e.g., FEI numbers like 3008156140 or 3021593788) and tailored specifications to meet varying clinical needs. The manufacturer provides detailed documentation for each variant to ensure proper selection, installation, and operation based on the intended diagnostic applications.

• What regulatory pathway does the Achieva Family follow?

  The Achieva Family MRI Systems are classified as Class 2 devices under FDA regulations and have obtained FDA 510(k) clearance (K043147). This pathway confirms that the devices are substantially equivalent to a legally marketed predicate device, ensuring they meet established safety and performance standards. The systems are also regulated under the Radiation-Emitting Products category, specifically for MRI systems, and must comply with electromagnetic compatibility and safety standards for MRI-safe environments.

• How should the Achieva Family MRI Systems be stored and maintained?

  The Achieva Family MRI Systems require proper storage and maintenance to ensure optimal performance and safety. They should be stored in a controlled environment, protected from physical damage, extreme temperatures, and electromagnetic interference. Regular maintenance, including calibration and servicing by trained technicians, is essential to uphold the system’s accuracy, reliability, and compliance with manufacturer guidelines. Adherence to these protocols extends the device’s lifespan and ensures consistent diagnostic imaging quality.