Surgical light systems recalled over powder coating stress lines and chipping
Chromophare surgical light systems and an associated upgrade kit are being recalled because stress lines in the powder coating indicate that the coating can chip.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a cosmetic-surface defect with no stated hazard or reported harm, which falls under the minor-defect rather than risk-of-harm criterion.
Plain-English summary
Chromophare Surgical Light Systems (REF CH00000001) and the SLX to Oculan NFC Upgrade Kit (REF P60034) are being recalled after stress lines were found forming on the powder coating, which indicates that powder coating chipping can occur.
Forty units are covered. The affected products carry UDI-DIs 07613327296167 and 07613327651317 and were distributed in Texas, Illinois, New York, Utah, Oregon, Arizona, Vermont and Minnesota. The FDA has classified the action as Class II.
The enforcement record describes the coating condition and does not state any injury or clinical consequence. Affected facilities should follow the manufacturer's instructions for inspection or correction of the identified units.
The recalled product
- Product
- Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
- Manufacturer
- Stryker Communications
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 7000010117
- 7000010118
- 7000010119
- 7000010120
- 7000010121
- 7000010122
- 7000010123
- 7000010124
- 7000010125
- 7000010141
- 7000010142
- 7000010177
- 7000010178
- 7000010148
- 7000010149
- 7000010157
- 7000010137
- 7000010175
- 7000010176
- 7000010145
Distribution
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