Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 19, 2014
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
Clarity Medical Systems Inc recalled RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, … — a moderate-severity action.
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, … was recalled by Clarity Medical Systems Inc in March 19, 2014. Reason: Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.…. Check the official notice for the remedy. Verify recall #Z-1154-2014 with the FDA Devices before acting.
The recall
Clarity Medical Systems Inc issued this moderate-severity FDA Devices recall — Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.….
- Moderate
- severity level
- Class II
- classification
- March 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1154-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1154-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on January 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Clarity Medical Systems Inc is listed as the recalling firm, operating out of Pleasanton, CA. Federal records list the affected scope as 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables..
The documented reason for this recall is: Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Aus…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.
Related Recalls
6
6 from same agency
Product description
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Reason for recall
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1154-2014 |
| Date reported | March 19, 2014 |
| Date initiated | January 24, 2014 |
| Recalling firm | Clarity Medical Systems Inc |
| Firm location | Pleasanton, CA |
| Affected scope | 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables. |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Ban… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1154-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.. Recalled by Clarity Medical Systems Inc. Units affected: 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables..
Why was this product recalled? ▼
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1154-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Bangladesh, Belarus, The Netherlands, Brazil, Bulgaria, Chile, China, Columbia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,India, Indonesia, Iran, United Kingdom, Israel, Italy, Kuwait, Lebanon, Malaysia, Mexico, Sweden, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Taiwan, Thailand, Turkey, UAE, Argentina, Uzbekistan, Oman, Canada, Germany, and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1154-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 19, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.