Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 26, 2018
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mazor Robotics Ltd recalled Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295)… - a moderate-severity action.
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295)… was recalled by Mazor Robotics Ltd in December 26, 2018. Reason: In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the c…. Check the official notice for the remedy. Verify recall #Z-0609-2019 with the FDA Devices before acting.
The recall
Mazor Robotics Ltd issued this moderate-severity FDA Devices recall-In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the c….
- Moderate
- severity level
- 5 units
- affected scope
- Class II
- classification
- December 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0609-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0609-2019) was formally reported on December 26, 2018, with the manufacturer initiating the action on November 26, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Mazor Robotics Ltd is listed as the recalling firm, operating out of North Industrial Park. Federal records list the affected scope as 5 units.
The documented reason for this recall is: In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. Distribution data in the federal record shows the product reached: Affected devices were distributed in the US to four different medical facilities in four states. 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 - 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 - 40,422 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
5 units
Related Recalls
6
0 from same agency
Product description
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
Reason for recall
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0609-2019 |
| Date reported | December 26, 2018 |
| Date initiated | November 26, 2014 |
| Recalling firm | Mazor Robotics Ltd |
| Firm location | North Industrial Park |
| Affected scope | 5 units |
| Distribution | Affected devices were distributed in the US to four different medical facilities in four states |
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-0609-2019) 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? ▼
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.. Recalled by Mazor Robotics Ltd. Units affected: 5 units.
Why was this product recalled? ▼
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0609-2019.
Where was the recalled product distributed? ▼
Distribution: Affected devices were distributed in the US to four different medical facilities in four states.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0609-2019) 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 December 26, 2018. 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.