Oculus Pentacam AXL Software Recall for Erroneous Quality Markings
Oculus Optikgeraete GmbH is recalling 83 Pentacam AXL devices due to a software anomaly that may produce erroneous quality specification markings.
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: The recall is classified as FDA Class II, and the source text describes a software anomaly that may produce erroneous markings without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Oculus Optikgeraete GmbH is recalling 83 units of the OCULUS Pentacam AXL, Model 70100, in the United States. The affected devices are equipped with software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The Pentacam AXL is a medical device designed to take photos of the anterior segment of the eye to evaluate corneal shape, analyze the lens, and assist physicians in determining intraocular lens power.
The recall was initiated because the device software versions contain an anomaly which may produce an erroneous marking for the quality specification value. This defect could potentially affect the accuracy of the device's quality specifications.
The affected devices were distributed to the states of California and Florida. There were no foreign, military, or government accounts involved in the distribution. Users should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil
- Manufacturer
- Oculus Optikgeraete GMBH
- Affected units
- 83
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)
- Serial numbers: 70100 0021 6190
- 70100 0301 5170
- 70100 0311 6150
- 70100 0331 7130
- 70100 0401 5101
- 70100 0421 6101
- 70100 0641 7170
- 70100 0831 7150
- 70100 1021 6190
- 70100 1101 5170
- 70100 1541 7170
- 70100 1631 7140
- 70100 1731 7140
- 70100 1831 7150
- 70100 1901 6130
- 70100 2211 6150
- 70100 2221 6190
- 70100 2231 7130
- 70100 2241 7160
- 70100 2511 6170
Distribution
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