Precision Spectra ™ SC-4401

• FDA PMA P150031 decided 8 Dec 2017 Active· +1 more in the status table
• FDA GUDID UDI-DI 08714729821557 listed 9 Nov 2015 Listed

• • Ongoing Z-2879-2026 FDA Class I ·initiated 17 Jun 2026

  Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

• • Ongoing Z-2404-2026 FDA Class II ·initiated 29 Apr 2026

  Sterile anchors my lack sterility assurance.

• • Ongoing Z-2558-2025 FDA Class II ·initiated 8 Jul 2025

  Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

• • Ongoing Z-2340-2025 FDA Class II ·initiated 8 Jul 2025

  Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

• • Ongoing Z-2617-2024 FDA Class II ·initiated 17 Jul 2024

  Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

• • Ongoing Z-1890-2024 FDA Class II ·initiated 18 Apr 2024

  Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

• • Terminated Z-2123-2020 FDA Class II ·initiated 24 Apr 2019

  The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

• 6 recalls, same reason

  • Terminated Z-2122-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2125-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2121-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2120-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2124-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2119-2020 FDA Class II ·initiated 24 Apr 2019

  The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

• • Terminated Z-1409-2010 FDA Unclassified (pre-2012) ·initiated 19 Mar 2010

  Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.

• • Terminated Z-0271-2009 FDA Unclassified (pre-2012) ·initiated 22 Sep 2008

  Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on

• • Terminated Z-1441-2012 FDA Unclassified (pre-2012) ·initiated 22 Apr 2008

  The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.

• • Terminated Z-0960-2008 FDA Unclassified (pre-2012) ·initiated 5 Oct 2007

  Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted t

• • Terminated Z-0055-2008 FDA Unclassified (pre-2012) ·initiated 3 Aug 2007

  Mislabeled: Product labeled with the incorrect shelf-life information.

• • Terminated Z-0700-2007 FDA Unclassified (pre-2012) ·initiated 30 Jan 2007

  The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.

• • Terminated Z-0299-2007 FDA Unclassified (pre-2012) ·initiated 21 Sep 2006

  A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.

• • Terminated Z-0396-05 FDA Unclassified (pre-2012) ·initiated 11 Nov 2004

  A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.

1. 24 Apr 2019 Recall initiated FDA recalls Z-2121-2020
2. 24 Apr 2019 Recall initiated FDA recalls Z-2120-2020
3. 24 Apr 2019 Recall initiated FDA recalls Z-2124-2020
4. 24 Apr 2019 Recall initiated FDA recalls Z-2119-2020
5. 18 Apr 2024 Recall initiated FDA recalls Z-1890-2024
6. 17 Jul 2024 Recall initiated FDA recalls Z-2617-2024
7. 8 Jul 2025 Recall initiated FDA recalls Z-2558-2025
8. 8 Jul 2025 Recall initiated FDA recalls Z-2340-2025
9. 29 Apr 2026 Recall initiated FDA recalls Z-2404-2026
10. 17 Jun 2026 Recall initiated FDA recalls Z-2879-2026

14 earlier events are in the sections above.

Trade name

Precision Spectra ™

Generic name

Deep brain electrical stimulation system

Model / reference

SC-4401

Primary DI / UDI-DI

08714729821557

PMA number

P030017 ↗

P150031 ↗

FDA product code

MHY, PJS, LGW, NHL, QRB

GMDN term

Deep brain electrical stimulation system

Device class

Class III

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Deep brain electrical stimulation system,Implantable pulse generator port plug

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