Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 26, 2013
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Res…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Aperio Technologies Inc recalled Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automate… - a moderate-severity action.
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automate… was recalled by Aperio Technologies Inc in June 26, 2013. Reason: Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for speci…. Check the official notice for the remedy. Verify recall #Z-1549-2013 with the FDA Devices before acting.
The recall
Aperio Technologies Inc issued this moderate-severity FDA Devices recall-Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for speci….
- Moderate
- severity level
- 364 units
- affected scope
- Class II
- classification
- June 26, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1549-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1549-2013) was formally reported on June 26, 2013, with the manufacturer initiating the action on February 22, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Aperio Technologies Inc is listed as the recalling firm, operating out of Vista, CA. Federal records list the affected scope as 364.
The documented reason for this recall is: Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in di… Distribution data in the federal record shows the product reached: Nationwide Distribution - including all states, none internationally .. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
364
Related Recalls
6
3 from same agency
Product description
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
Reason for recall
Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1549-2013 |
| Date reported | June 26, 2013 |
| Date initiated | February 22, 2013 |
| Recalling firm | Aperio Technologies Inc |
| Firm location | Vista, CA |
| Affected scope | 364 |
| Distribution | Nationwide Distribution - including all states, none internationally . |
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-1549-2013) 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? ▼
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.. Recalled by Aperio Technologies Inc. Units affected: 364.
Why was this product recalled? ▼
Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2013. Severity: Moderate. Recall number: Z-1549-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution - including all states, none internationally ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1549-2013) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 26, 2013. 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 July 2026.