Recall events
/
Event 63596
Event summary
Timeline bucket October 25, 2012
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Carl Zeiss Meditec, Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
3 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Z-0404-2013
Recall number Z-0404-2013
Initiated October 25, 2012
Classification Class II
Status Terminated
Quantity 36 tootal, all lots
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
manufacturing defect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0404-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[12901]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Code information Part number 304534-7500-000; lot number 540958.
Distribution pattern Nationwide Distribution including IL and MD
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16033]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Z-0405-2013
Recall number Z-0405-2013
Initiated October 25, 2012
Classification Class II
Status Terminated
Quantity 36 total, all lots
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
manufacturing defect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0405-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43939]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Code information Part number 304534-7500-001; lot number 540959.
Distribution pattern Nationwide Distribution including IL and MD
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16007]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Z-0406-2013
Recall number Z-0406-2013
Initiated October 25, 2012
Classification Class II
Status Terminated
Quantity 36 total, all lots
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
manufacturing defect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0406-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48818]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Code information Part number 304534-7500-002; lot number 540960.
Distribution pattern Nationwide Distribution including IL and MD
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17065]
FDA event record
· Exact recall-number query on openFDA
