Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 29, 2013
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000…
Boston Scientific Crm Corp recalled LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Man… - a moderate-severity action.
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Man… was recalled by Boston Scientific Crm Corp in May 29, 2013. Reason: Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3…. Check the official notice for the remedy. Verify recall #Z-1339-2013 with the FDA Devices before acting.
The recall
Boston Scientific Crm Corp issued this moderate-severity FDA Devices recall-Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- May 29, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1339-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1339-2013) was formally reported on May 29, 2013, with the manufacturer initiating the action on April 10, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Boston Scientific Crm Corp is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 1.
The documented reason for this recall is: Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display… Distribution data in the federal record shows the product reached: Nationwide Distribution including DC and PR. 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
1
Related Recalls
6
3 from same agency
Product description
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Reason for recall
Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1339-2013 |
| Date reported | May 29, 2013 |
| Date initiated | April 10, 2013 |
| Recalling firm | Boston Scientific Crm Corp |
| Firm location | Saint Paul, MN |
| Affected scope | 1 |
| Distribution | Nationwide Distribution including DC and PR |
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-1339-2013) 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? ▼
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.. Recalled by Boston Scientific Crm Corp. Units affected: 1.
Why was this product recalled? ▼
Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2013. Severity: Moderate. Recall number: Z-1339-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including DC and PR.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1339-2013) 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 May 29, 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.