Recall events
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Event 89437
Event summary
Timeline bucket December 02, 2021
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Zenition 50, Model #718096
Z-0647-2022
Recall number Z-0647-2022
Initiated December 02, 2021
Classification Class II
Status Ongoing
Quantity 16 US; 76 ROW
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
firmware issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0647-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58202]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Code information Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231
Distribution pattern Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
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[35650]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Zenition 70, Model #718133
Z-0648-2022
Recall number Z-0648-2022
Initiated December 02, 2021
Classification Class II
Status Ongoing
Quantity 95 US; 284 ROW
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
firmware issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0648-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52023]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Code information Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231
Distribution pattern Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
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[34761]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Veradius Unity, Model #718132
Z-0649-2022
Recall number Z-0649-2022
Initiated December 02, 2021
Classification Class II
Status Ongoing
Quantity 12 US; 44 ROW
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
firmware issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0649-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39740]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Code information Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231
Distribution pattern Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
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[34751]
FDA event record
· Exact recall-number query on openFDA
