CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat recalled
Stryker Communications is recalling Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of, distributed nationwide in the US. The recall was initiated on 26 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0692-2018
- FDA event ID
- 79116
- Recalling firm
- Stryker Communications, Flower Mound, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2018
- FDA classified
- 23 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 26 Jan 2018 | Recall initiated by company | |
| 23 Feb 2018 | Classified by FDA | +28 days |
| 7 Mar 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The mounts on the monitor may have an insufficient (missing or incomplete) weld.
Product as listed by the FDA
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Where it was distributed
Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.
Questions about this recall
Why was it recalled?
The mounts on the monitor may have an insufficient (missing or incomplete) weld.
Which lots are affected?
United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International: Serial numbers 6145060-O11628 to 6176090-V14102
Where was it sold?
Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker Communications
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stryker Chromophare Softlit Ring Surgical Light System recalled | Stryker Communications | Device Malfunction | Nationwide |
| Device | CLASS II | Chromophare Surgical Light System recalled by Stryker Communications | Stryker Communications | Other | Nationwide |
| Device | CLASS II | Chromophare Surgical Light System recalled by Stryker Communications | Stryker Communications | Potency & Assay | TX |
| Device | CLASS II | S-Series Equipment Management System recalled by Stryker Communications | Stryker Communications | Other | Nationwide |
| Device | CLASS II | Berchtold Chromophare Ceiling Mounted Surgical Light System recalled | Stryker Communications | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |