Radiosurgery systems recalled over software defect that could cause collimator collision
Zap Surgical Systems is recalling 17 ZAP-X Radiosurgery Systems because a software defect could let the collimator collide with a patient's shoulders or the patient table.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a collimator collision with a patient is a physical hazard, and the record reports no injuries.
Plain-English summary
ZAP-X Radiosurgery Systems, model 300150, are being recalled for a software defect involving proximity error handling.
If the system triggers a proximity error message during a long gantry move of more than 180 degrees, and a further proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with the patient's shoulders or the patient table.
The recall covers 17 units carrying UDI-DI 00860183001504, distributed worldwide including in Florida, Colorado, New Jersey and New York, and to countries including Germany and France. The FDA has classified the action as Class II.
The enforcement record describes the collision potential and reports no injuries. Treatment centres running affected serial numbers should follow the firm's instructions.
The recalled product
- Product
- ZAP-X Radiosurgery System, Model: 300150
- Manufacturer
- Zap Surgical Systems
- Affected units
- 17
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 (18)
- UDI-DI: 00860183001504
- Serial Numbers: ZUC17153
- ZUC20156
- ZUC20157
- ZUC20159
- ZUC21162
- ZUC21164
- ZUC22166
- ZUC22169
- ZUC22170
- ZUC22171
- ZUC22173
- ZUC22174
- ZUC23176
- ZUC23177
- ZUC24179
- ZUC24180
- ZUC24181. Software version: TDS V1.10.1
Distribution
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