Home / Recalls / Stryker Communications / Z-2540-2019

Z-2540-2019 Class II Ongoing

Recalled by Stryker Communications — Flower Mound, TX

FDA device recall Z-2540-2019 was initiated by Stryker Communications on March 22, 2019 and is designated Class II. Reason for recall: The back cover of the light head was insufficiently assembled and could potentially fall off the light. The recall status is ongoing. Affected quantity: 3,344 lights.

Recall Details

Product Type: Devices
Report Date: September 18, 2019
Initiation Date: March 22, 2019
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,344 lights

Product Description

Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.

Reason for Recall

The back cover of the light head was insufficiently assembled and could potentially fall off the light.

Distribution Pattern

Distribution was nationwide, including to Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Austria, Australia, Belgium, Bulgaria, Canada, China, Colombia, Denmark, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Kazakhstan, Korea, Kuwait, Lithuania, Mexico, Netherlands, Philippines, Poland, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.

Code Information

Serial number ranges: 83171-0017818 to 83171-0123938

Other recalls by Stryker Communications

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Z-2620-2025 Class II — Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Ki (July 15, 2025)
Z-1506-2024 Class II — Chromophare Surgical Light System , REF CH00000001 (February 8, 2024)
Z-1297-2021 Class II — S-Series Equipment Management System; Model Number(s):0682400550; UDI: 076133274 (January 29, 2021)
Z-1602-2020 Class II — Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 (October 11, 2019)
Z-2446-2019 Class II — Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component o (August 1, 2019)
Z-2539-2019 Class II — Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lig (March 22, 2019)
Z-1388-2019 Class II — EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgica (November 13, 2018)
Z-0828-2018 Class II — Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 (January 29, 2018)
Z-0692-2018 Class II — Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component o (January 26, 2018)