CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Berchtold Chromophare Ceiling Mounted Surgical Light System recalled
Stryker Communications is recalling Berchtold Chromophare Ceiling Mounted Surgical Light System, distributed nationwide in the US. The recall was initiated on 29 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-0828-2018
- FDA event ID
- 79251
- Recalling firm
- Stryker Communications, Flower Mound, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2018
- FDA classified
- 1 Mar 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 29 Jan 2018 | Recall initiated by company | |
| 1 Mar 2018 | Classified by FDA | +31 days |
| 7 Mar 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
Product as listed by the FDA
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights 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. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.
Where it was distributed
Worldwide Distribution - US Nationwide Distribution and in the countries of Canada.
Questions about this recall
Why was it recalled?
The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
Which lots are affected?
Serial numbers distributed in the U.S.: 022817-71019, 22817-71033, 022817-71034, 022817-71035, 022817-71048, 022817-71049, 022817-71050, 022817-71051, 030817-71104 030817-71105, 030817-71106, 030817-71107, 030817-71108, 030817-71109, 030817-71110, 030817-71111, 030817-71114, 030817-71115, 030817-71116, 030817-71117, 030817-71120, 030817-71121, 030817-71122, 030817-71123, 030817-71124, 030817-71125, 030817-71126, 030817-71127, 030817-71128, 030817-71129, 030817-71130, 030817-71131, 030817-71132, 30817-71133, 030817-71134, 030817-71135, 030817-71136, 030817-71137, 030817-71139, 030817-71140, 030817-71141, 030817-71142, 030817-71143, 030817-71144, 030817-71145, 030817-71146, 030817-71147, 030817-71148, 030817-71149, 030817-71151, 030817-71152, 030817-71153, 031417 -71180, 031417 71198, 031417-71154, 031417-71155, 031417-71156, 031417-71157, 031417-71158, 031417-71164, 031417-71165, 031417-71166, 031417-71167, 031417-71170, 031417-71171, 031417-71172, 031417-71173, 031417-71174, 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081117-73042, 081117-73043, 081117-73044, 081217-73058, 081217-73059, 081217-73060, 081217-73061, 081217-73062, 081217-73064, 081417-72926, 081417-73066, 081417-73068, 081417-73070, 081417-73072, 081417-73082, 081417-73083, 081417-73084, 081417-73085, 081417-73086, 081417-73087, 081417-73088, 081517-71788, 081617-73094, 081617-73095, 081617-73096, 081617-73097, 081617-73098, 081617-73099, 081617-73100, 081617-73101, 081617-73102, 081617-73103, 081617-73104, 081617-73105, 081617-73106, , 081617-73107, 081717-73115, 081717-73116, 081717-73117, 081717-73127, 081717-73129, 081717-73130, 081717-73131, 081817-73140, 081817-73142, 081817-73149, 081817-73150, 081817-73151, 081817-73152, 081817-73153, 081817-73154, 081817-73155, 081817-73156, and 081817-73158. Serial numbers distributed to Canada: 022817-71044, 030817-71150, 031417-71159, 031417-71160, 031417-71161, 031417-71162, 031417-71168, 032017-71226, 032017-71227, 040517-71418, 041217-71472, 041217-71473, 041817-71520, 042017-71591, 042017-71592, 042017-71663, 042017-71665, 050317-71725, 050317-71740, 050317-71762, 050817-72167, 051317-71763, 053117-72069, 053117-72070, 060817-72101, 060817-72103, 060817-72168, 060817-72169, 060817-72170, 062917-72456, 073117-72874, 073117-72876, 073117-72877, 073117-72878, 073117-72879, 073117-72880, 080917-73012, 080917-73015, 080917-73018, 080917-73021, 081617-73108, 081617-73109, 081617-73110, 081617-73112, 081617-73113, and 081717-73124
Where was it sold?
Worldwide Distribution - US Nationwide Distribution and in the countries of Canada.
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 |
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|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |